2ABG7-TBG-460Blood Glucose / Cholesterol 2 in 1 Monitoring System

Blood Glucose / Cholesterol 2 in 1 Monitoring System User's Manual 2015/07/14 Rev.01 www.trulyinstrument.com Model: TBG-460GC Chapter 1 TRULY TBG-460GC Monitoring System 1.1 Introduction.............................................................................. 1.2 Precautions.............................................................................. 1.3 Intended Use............................................................................ 1.4 Labelling and Informations..................................................... 1.5 System Components............................................................... Chapter 2 Setup the meter 2.1 Set the Year/Month/Day/Hour/Minute/ Measurement unit........ Chapter 3 How to perform Test 3.1 Before Testing.......................................................................... 3.2 Connect iOS device via Bluetooth.......................................... 3.3 Perform the Blood Glucose Test............................................. ......................................... 3.5 Special messages.................................................................. 3.6 Care after the test.................................................................. Chapter 4 ............................................................ Chapter 5 Meter Memory Function.............................................. Chapter 6 Installing/Replacing the Batteries................................ Chapter 7 Storage and Handling of Meter and Strips.................. Chapter 8 Error Message and Trouble Shooting.......................... Chapter 9 Specification................................................................ FCC Statement.............................................................................19 3.4 Perform the Total Cholesterol Test Quality Control 2 2 3 4 4 6 7 9 10 11 12 12 13 14 15 16 16 18 -1- Table of Contents -2- Chapter 1 TRULY TBG-460GC Monitoring System 1.1 Introduction Thank you for choosing TRULY Blood Glucose / Cholesterol Monitoring System. Please read the "User's Manual" for your convenient and for safe use. The TRULY Blood Glucose / Cholesterol Monitoring System provides you with accurate, plasma-calibrated results based on electrochemical sense technology and the superior capillary sampling. The TRULY Blood Glucose / Cholesterol Monitoring System require only a small amount of blood, the result is precisely calculated and displayed. Please read the entire "User's Manual" carefully before using the TRULY Blood Glucose / Cholesterol Monitoring System. The "User's Manual" guides you through the operation procedures with illustrated directions and help you find the required informations. Please contact the local distributor for questions and enquiries. WARNING: Please carefully read the instructions in this "User's Manual" and become familiar with the test procedures before using the system. User should do the quality check and consult with a healthcare professional before doing any important medical decision. 1.2 Precautions Please observe the following limitations for obtaining accurate results of TRULY Blood Glucose / Cholesterol Monitoring System. - The measurements are only for reference purposes. For an analysis of the measurements, consult specialists. - For In-vitro diagnostic use only (External use only). - Single use only, please do not reuse the test strip. - Do not use this product for those who cannot express their opinions properly including infants or babies. -3- - Handle the strip with clean and dry hands; lancing site for the test should be cleaned and dried thoroughly. - Do not perform the test while a cell phone is used beside; prevent the electronic signal interference. - Oxygen concentration in air is low may cause the test inaccurate; there is no effect from altitude up to 10,000 feet above sea level. - Medical therapy for intravenous injection, such as immunoglobulin preparations and peritoneal dialysis solutions,containing sugar compounds may cause higher test results. - Hematocrit (Hct) range from 30-55% is acceptable.Hct less than 30% may cause elevated result.Hct above 55% may cause reduced glucose results versus a whole blood reference. - Do not drop the product. - Keep the lancets and lancing device out of the reach of the children. o - Keep the meter and test strips at room temperature (10-30C). 1.3 Intended Use Truly TBG-460GC Blood Glucose and Cholesterol Monitoring System is intended to be used for quantitative measurement of blood glucose level and cholesterol level in fresh capillary whole blood drawn from the fingertips. It is intended for use outside of body (In Vitro diagnostic use). It should be use only as an aid to monitor blood glucose and cholesterol level by individuals at home and by healthcare professionals at clinical settings. The devices features include Bluetooth function, the measurement result could be send out via Bluetooth protocol. -4- 1.4 Labelling and Informations Do not re-use Keep dry Operation temperature limitation In-vitro diagnostic Lot number CE certification Read instructions Caution, consult accompanying documents Storage temperature limitation Use by EU Representative Catalogue number (Product number) Manufactured by 0123 1.5 System Components 设定 Test Strip Port: Insert test strip here. The meter will turn on automatically. LCD Screen : For display of operating information and test results. Memory Button : Enter memory mode operation. Down ButtonUp Button Meter (Front Side) Cholesterol Test Strip(Yellow Color) Electronic Contact Bar : Insert Electronic Contact Bar of the test strip into the Test Port of the meter to activate it. Sample Inlet : The inlet where the whole blood or control solution is drawn in. Touching a blood sample or control solution will result in a capillary action automatically. At least 10uL of blood sample is essential. Reaction Zone : Reaction zone of Total Cholesterol CHOL Glucose Test Strip (Blue Color) Sample Inlet : The inlet where the whole blood …

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Blood Glucose Monitoring System Model: TBG-460G Power: One 3V (CR2032) lithium battery FCC ID: 2ABG7-TBG-460 Manufacturer: Truly Instrument limited Made in China SIZE: 34.5*16.5MM Blood Glucose/Cholesterol 2 in 1 Monitoring System Model: TBG-460GC Power: One 3V (CR2032) lithium battery Manufacturer: Truly Instrument limited FCC ID: 2ABG7-TBG-460 Made in China SIZE: 34.5*16.5MM -0039

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BT antenna

TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 RF exposure Estimation for TBG-460GC 1. Introduction TBG-460GC is a Blood Glucose and Total Cholesterol Monitoring System, which contain Bluetooth function inside. 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 = 0.26mW Distance = 5 mm f = 2.480 GHz [0.26/5] * SQRT(2.480) =0.20 0.07 ≤ 3.0 Therefore, excluded from SAR testing. TUV SUD China, Shenzhen Branch Reviewed by: Prepared By: Cookies Bu/ Senior EMC Project Manager Calvin Weng/EMC Project Engineer Date: 2015-08-17 Date: 2015-08-17

Report Number: 68.730.15.049.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 1 of 24 FCC- TEST REPORT Report Number : 68.730.15.049.01 Date of Issue: 26 August 2015 Model : TBG-460GC, TBG-460G Product Type : Blood Glucose and Total Cholesterol Monitoring System Applicant : Truly Instrument Ltd. Address : Truly Industrial Area, Shanwei City,Guangdong Province, China Production Facility : Truly Instrument Ltd. Address : Truly Industrial Area, Shanwei City,Guangdong Province, China Test Result :  Positive  Negative Total pages including Appendices : 24 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen 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. Shenzhen 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. Shenzhen 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. Shenzhen 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: 68.730.15.049.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 2 of 24 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 6dB bandwidth .......................................................................................................................................................... 11 9.3 Power spectral density ............................................................................................................................................. 13 9.4 Spurious RF conducted emissions ........................................................................................................................ 14 9.5 Band edge ................................................................................................................................................................. 18 9.6 Spurious radiated emissions for transmitter ......................................................................................................... 20 10 Test Equipment List ...................................................................................................................................................... 23 11 System Measurement Uncertainty ............................................................................................................................. 24 Report Number: 68.730.15.049.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 3 of 24 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 City, 518052, P. R. China Telephone: 86 755 8828 6998 Fax: 86 755 828 5299 Report Number: 68.730.15.0…

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Radiated emission below 1GHz Radiated emission above 1GHz