OU9TMB1973BSBlood Pressure Monitor with Bluetooth

User Manual Blood Pressure Monitor AKTIIA INIT I1 Please read the user manual carefully and thoroughly to ensure the safe usage of this product. Keep the manual for your furthe r reference in case you have problems. Thank you very much for selecting AKTIIA Blood Pressure Monitor AKTIIA INIT I1. Arm Type 3 111516 Table of ContentsINTRODUCTIONGeneral DescriptionIndications for UseContraindicationsMeasurement PrincipleSafety InformationSymbols meaningMonitor ComponentsListBEFORE YOU STARTPower Supply and ChargingTie the cuffMEASUREMENTStart MeasurementINFORMATION FOR USERTips for MeasurementMaintenanceComponent list of pressure measuring system 20 17 ABOUT BLOOD PRESSUREWhat are systolic pressure and diastolic pressure?What is the standard blood pressure classification?Why does my blood pressure fluctuate throughout the day?Why do I get a different blood pressure at home compared to the hospital?Is the result the same if measuring on the right arm?SPECIFICATIONS 22 FCC STATEMENT 2325 COMPLIED EUROPEAN STANDARDS LIST EMC GUDIANCEWhat you need to pay attention to when you measure your blood pressure at home? INTRODUCTION General DescriptionThank you for selecting AKTIIA arm type blood pressure monitor (AKTIIA INIT I1). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service.Readings taken by this mornitor are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultat ion method. This manual contains important safety and care information, and provides step by step instructions for using the product.Please read the manual thoroughly before using the productIndications for UseThe AKTIIA Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and and heart rate in adult s with arm                 d for indoor use only. Contraindications1.The device should not be used by any person who may be suspected of, or is pregnant .2.The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators . Measurement Principle This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero pressure” equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure o scillations generated      ! !" #$$      $  !  astolic pressure, and also pulse rate. 3 Safety InformationThe signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. 4 Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”Symbol for “Authorised Representative in the European Community EC REP SN Symbol for “TYPE BF APPLIED PARTS” Symbol for “THE OPERATION GUIDE MUST BE READ” Symbol for “COMPLIES WITHMDD 93/42/EEC REQUIREMENTS”Symbol for “MANUFACTURER”Symbol for “SERIAL NUMBER” Symbol for “DIRECT CURRENT” Symbol for “MANUFACTURE DATE” Caution: These notes must be observed to prevent any damage to the device. Symbol for “RECYCLE” The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods. CAUTION 5 * This device is intended for adult use in homes only. * The device is not suitable for use on neonatal patients, pregnant women,patients with implanted, electronical devices, patien ts with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or peop le who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses.* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.* The device is not intended for public use.* This device is intended for non-invasive measuring and monitoring of arterial blood pressure.It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement . * Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end m edical treatment without asking a physician for treatment advice.* If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Ne ver change a prescribed medication without consulting your physician.* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a d octor. Consult your doctor if you have any question about your blood pressure.* When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atri al fibrillation, the results might be inaccurate. Please consult your physician about the result.* When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood ci rculation of the patient, thus cause harmful injury to the patient: consecutive multiple measurements; the application of the cuff and its pressurization on any arm where intravascular a ccess or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a mastectomy.* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because this co uld cause temporary loss of function of those simultaneously-used monitoring ME equipment.*On the rare occasion of a fault causing the cuff to remai…

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Guangdong Transtek Electronics Co.,Ltd. Date (2020-02-18) TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Confidentiality Request FCC ID: OU9TMB1973BS Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, Guangdong Transtek Medical Electronics Co., Ltd，Zone B, No.105 ,Dongli Road, Torch Development District,528437,Zhongshan,Guangdong,China hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Company Officer: Kevin Tan Telephone Number: +86-760-85166220 Email:[email protected]

Guangdong Transtek Electronics Co.,Ltd. Date (2020-02-18) TUV SUD BABT TCB/FCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Dear Sir or Madam, We, (Guangdong Transtek Medical Electronics Co.,Ltd), hereby authorize Kevin Ouyang TÜV SÜD China Project Engineer / EMC Department 5F, Communication Building, 163 Pingyun Rd, Huangpu Ave. West Guangzhou, P.R.China 020-38170584) to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. FCC ID: OU9TMB1973BS This authorization period is for one year. Sincerely, Company Officer:Kevin Tan Telephone Number:+86-760-85166220 Email: [email protected]

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Report Number: 64.790.19.06028.01-RF Page 1 of 1 TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch 5F, Communication Building,163 Pingyun Rd, Huangpu Ave. West Guangzhou, P.R.China TEL: +86 20 3832 0668 FAX: +86 20 3832 0478 RF exposure Estimation for AKTIIA INIT I1 1. Introduction AKTIIA INIT I1 is Blood Pressure Monitor, which contain Bluetooth function inside. FCC ID: OU9TMB1973BS 2. Limit and Guidelines on Exposure to Electromagnetic Fields According to §15.247(e)(i) and §1.1307(b)(1), systems operating under the provisions of this section shall be operated in a manner that ensure that the public is not exposed to radio frequency energy level in excess of the Commission’s guideline. According to KDB 447498 D01 Mobile Portable RF Exposure v05r02, no SAR required if power is lower than the flowing threshold: The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(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 calculation25 • 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. 3. Calculation method [(max. power of` channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 3.0 Conducted Power + tune up tolerance = 0.798mW Distance = 5 mm f = 2.480 GHz [0.798/5] * SQRT(2.480) =0.25 0.25 ≤ 3.0 Therefore, excluded from SAR testing. TUV SUD China, Guangzhou Branch Reviewed by: Prepared By: Tony Liu / Project Reviewer Kevin Ouyang / Project Handler Date: 2020-03-24 Date: 2020-03-24

Report Number: 64.790.19.06028.01 Page 1 of 31 TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch 5F, Communication Building,163 Pingyun Rd, Huangpu Ave. West Guangzhou, P.R.China TEL: +86 20 3832 0668 FAX: +86 20 3832 0478 FCC - TEST REPORT Report Number : 64.790.19.06028.01 Date of Issue: 2020-02-24 Model : AKTIIA INIT I1 Product Type : Blood Pressure Monitor Applicant : Guangdong Transtek Medical Electronics Co.,Ltd Address : Zone A, No.105, Dongli Road, Torch Development District, 528437 : Zhongshan, Guangdong, China Production Facility : Guangdong Transtek Medical Electronics Co.,Ltd Address : Zone B, No.105, Dongli Road, Torch Development District, 528437 : Zhongshan, Guangdong, China Test Result : ◼ Positive  Negative Total pages including Appendices : 31 TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch is a subcontractor to TÜV SÜD Product Service GmbH according to the principles outlined in ISO 17025. TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch reports apply only to the specific samples tested under stated test conditions. Construction of the actual test samples has been documented. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. The manufacturer/importer is responsible to the Competent Authorities in Europe for any modifications made to the production units which result in non-compliance to the relevant regulations. TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval. Report Number: 64.790.19.06028.01 Page 2 of 31 TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch 5F, Communication Building,163 Pingyun Rd, Huangpu Ave. West Guangzhou, P.R.China TEL: +86 20 3832 0668 FAX: +86 20 3832 0478 1 Table of Contents 1 Table of Contents ................................................................................................................................ 2 2 Details about the Test Laboratory .................................................................................................... 3 3 Description of the Equipment Under Test ....................................................................................... 4 4 Summary of Test Standards .............................................................................................................. 5 5 Summary of Test Results ................................................................................................................... 6 6 General Remarks ................................................................................................................................ 7 7 Test Setups .......................................................................................................................................... 8 8 Systems test configuration ................................................................................................................. 9 9 Technical Requirement .................................................................................................................... 10 9.1 Conducted peak output power ................................................................................................. 10 9.2 Power spectral density .............................................................................................................. 13 9.3 6 dB Bandwidth and 99% Occupied Bandwidth.................................................................... 16 9.4 Spurious RF conducted emissions .......................................................................................... 20 9.5 Band edge ................................................................................................................................... 24 9.6 Spurious radiated emissions for transmitter .......................................................................... 26 10 Test Equipment List ....................................................................................................................... 30 11 System Measurement Uncertainty .............................................................................................. 31 Report Number: 64.790.19.06028.01 Page 3 of 31 TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch 5F, Communication Building,163 Pingyun Rd, Huangpu Ave. West Guangzhou, P.R.China TEL: +86 20 3832 0668 FAX: +86 20 3832 0478 2 Details about the Test Laboratory Details about the Test Laboratory Test Site 1 Company name: TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12 & 13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District Shenzhen 518052 P.R. China Telephone: 86 755 8828 6998 Fax: 86 755 8828 5299 FCC Registration No.: 514049 Report Number: 64.790.19.06028.01 Page 4 of 31 TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch 5F, Communication Building,163 Pingyun Rd, Huangpu Ave. West Guangzhou, P.R.China TEL: +86 20 3832 0668 FAX: +86 20 3832 0478 3 Description of the Equipment Under Test Product: Blood Pressure Monitor Model no.: FCC ID: AKTIIA INIT I1 OU9TMB1973BS Options and accessories: N/A Rating: Internal Battery:3.7VDC DC input:5V RF Transmission Frequency: 2402MHz-2480MHz No. of Operated Channel: 40 Modulation: GFSK Antenna Type: Internal Antenna Antenna Gain: 0dBi Description of the EUT: The Equipment Under Test (EUT) AKTIIA INIT I1 is Blood Pressure Monitor with Bluetooth operated at 2.402-2.48GHz Report Number: 64.790.19.06028.0…

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