TUKMIR061SmartOne

SmartOne Page 1 of 17 Rev.0.1 User manual SmartOne DRAFT VERSION User manual rev. 0.1 Issue date 05.01.2015 Approval date 05.01.2015 SmartOne Page 2 of 17 Rev.0.1 User manual INDEX 1. INTRODUCTION ............................................................................................................................................................................................ 3 1.1 Intended Use ............................................................................................................................................................................................ 3 1.1.1 User Category ...................................................................................................................................................................................... 3 1.1.2 Ability and experience required ....................................................................................................................................................... 4 1.1.3 Operating environment ..................................................................................................................................................................... 4 1.1.4 Subject effect on the use of the device ........................................................................................................................................... 4 1.1.5 Limitations of use - Contraindications ........................................................................................................................................... 4 1.2 Important safety warnings ..................................................................................................................................................................... 4 1.2.1 Danger of cross-contamination ....................................................................................................................................................... 5 1.2.2 Turbine ................................................................................................................................................................................................. 5 1.2.3 Mouthpiece .......................................................................................................................................................................................... 6 1.2.4 Device ................................................................................................................................................................................................... 6 1.3 Unforeseen errors .................................................................................................................................................................................... 6 1.4 Labels and symbols ................................................................................................................................................................................. 6 1.4.1 Identification label .............................................................................................................................................................................. 7 1.4.2 Electrical safety symbol ..................................................................................................................................................................... 7 1.4.3 Warning symbol for the WEEE Directive .................................................................................................................................... 7 1.4.4 Mark of conformity with the Medical Device Directive ............................................................................................................. 7 1.5 Product description ................................................................................................................................................................................. 7 1.6 Technical features .................................................................................................................................................................................... 8 1.6.1 Features of the spirometer ................................................................................................................................................................ 8 1.6.2 Other features ..................................................................................................................................................................................... 9 2. FUNCTIONING OF THE Smart One ® ..................................................................................................................................................... 10 2.1 Connection to PC .................................................................................................................................................................................. 10 2.2 Using the Smart One ® .......................................................................................................................................................................... 10 2.3 Spirometry Testing ................................................................................................................................................................................ 10 2.4 Spirometry test interpretation ............................................................................................................................................................. 10 3. MAINTENANCE ............................................................................................................................................................................................ 12 3.1 Cleaning and controlling the reusable turbine .................................................................................................................................. 12 4. PROBLEM SOLVING ..................................................…

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Report No.: BL-SZ1510007-601 ANNEX C EUT PHOTOS THE FRONT OF EUT THE BACK OF EUT Report No.: BL-SZ1510007-601 THE LEFT OF EUT THE RIGHT OF EUT Report No.: BL-SZ1510007-601 THE UP OF EUT THE DOWN OF EUT

Label: Label Location: Label location

Report No.: BL-SZ1510007-601 C.2 Inside of the EUT OPEN THE EUT PHOTO 1 OPEN THE EUT PHOTO 2 Report No.: BL-SZ1510007-601 EUT INTERNAL BOARD 1 EUT INTERNAL BOARD 2 BT Chip PCB Antenna Report No.: BL-SZ1510007-601 EUT INTERNAL BOARD 2 BT Chip

RF Exposure Evaluation For TUKMIR061 Refer user manual this device is a health detector with BLE module was designed used in portable devices the minimum distance between human’s body within 5mm. Based on the 47CFR 2.1093, this device belongs to portable device. The definition of the category as following: Portable Derives: CFR Title 47 §2.1093(b) (b) For purposes of this section, a portable device is defined as a transmitting device designed to be used so that the radiating structure(s) of the device is/are within 20 centimeters of the body of the user. FCC KDB 447498 D01 General RF Exposure Guidance v05r02 Limit 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. 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. 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 distanc e,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 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 is applied to determine SAR test exclusion. FCC exclusion condition= [ (0.25,mW) (5,mm) ] · [ � 2. 48 (GHz) ] = 0.079 ＜ 3.0 RF Exposure Evaluation Result: PA S S

Report No.: BL-SZ1510007-601 2 Revision History Version Issue Date Revisions Rev. 01 Mar. 4, 2015 Initial Issue TABLE OF CONTENTS 1 ADMINISTRATIVE DATA (GENERAL INFORMATION) .......................................................................... 5 1.1 Identification of the Testing Laboratory .............................................................................................. 5 1.2 Identification of the Responsible Testing Location ............................................................................. 5 1.3 Announce ........................................................................................................................................... 5 2 PRODUCT INFORMATION ...................................................................................................................... 6 2.1 Applicant ............................................................................................................................................ 6 2.2 Manufacturer ...................................................................................................................................... 6 2.3 General Description for Equipment under Test (EUT) ....................................................................... 6 2.4 Technical Information ......................................................................................................................... 6 2.5 Ancillary Equipment ........................................................................................................................... 6 3 SUMMARY OF TEST RESULTS .............................................................................................................. 7 3.1 Test Standards ................................................................................................................................... 7 3.2 Verdict ................................................................................................................................................ 7 4 GENERAL TEST CONFIGURATIONS ..................................................................................................... 8 4.1 Test Environments ............................................................................................................................. 8 4.2 Test Equipment List ........................................................................................................................... 8 4.3 Test Configurations ............................................................................................................................ 9 4.4 Description of Test Setup ................................................................................................................... 9 4.4.1 For Antenna Port Test ................................................................................................................. 9 4.4.2 For AC Power Supply Port Test .................................................................................................. 9 4.4.3 For Radiated Test (Below 30 MHz) ........................................................................................... 10 4.4.4 For Radiated Test (30 MHz-1 GHz) .......................................................................................... 10 4.4.5 For Radiated Test (Above 1 GHz) ............................................................................................. 11 4.5 Test Conditions ................................................................................................................................ 11 TEST ITEMS ........................................................................................................................................... 12 5.1 Antenna Requirements .................................................................................................................... 12 Report No.: BL-SZ1510007-601 3 5.1.1 Standard Applicable .................................................................................................................. 12 5.1.2 Antenna Anti-Replacement Construction .................................................................................. 12 5.1.3 Antenna Gain ............................................................................................................................ 12 5.2 Output Power ................................................................................................................................... 13 5.2.1 Test Limit ................................................................................................................................... 13 5.2.2 Test Procedure .......................................................................................................................... 13 5.3 6dB Bandwidth ................................................................................................................................. 14 5.3.1 Limit ........................................................................................................................................... 14 5.3.2 Test Procedure .......................................................................................................................... 14 5.4 Conducted Spurious Emission ......................................................................................................... 15 5.4.1 Limit ........................................................................................................................................... 15 5.4.2 Test Procedure .......................................................................................................................... 15 5.5 Conducted Emission ........................................................................................................................ 17 5.5.1 Limit ........................................................................................................................................... 17 5.5.2 Test Proc…

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Report No.: BL-SZ1510007-601 ANNEX B TEST SETUP PHOTOS B.1 Conducted Emissions Test Photo B.2 Radiated Test Photo Below 30MHz Report No.: BL-SZ1510007-601 30MHz to 1GHz Above 1GHz