
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
Page 1 of 27 For in vitro diagnostic use only Read instructions before use For self-testing iHealth TM Wireless Smart GlucoâMonitoring System (BG5) OWNERâS MANUAL Table of Contents INTRODUCTIN ...............................................................................................................................2 PACKAGE CONTENTS.................................................................................................................2 SETUP REQUIREMENTS ............................................................................................................4 INTENDED USE .............................................................................................................................4 How the Test Works? .....................................................................................................................5 IMPORTANT SAFETY INSTRUCTIONS ....................................................................................5 IMPORTANT TESTING INFORMATION.....................................................................................6 INFORMATION ABOUT ALTERNATIVE SITE TESTING (AST) .............................................6 What is Alternate Site Testing?.................................................................................................7 What is the Advantage of Alternative Site Testing? .................................................................7 When to Use Alternative Site Testing? .....................................................................................7 PARTS AND DISPLAY INDICATORS .........................................................................................9 Glucose Meter...........................................................................................................................9 Blood Glucose Test Strip .........................................................................................................10 SETUP PROCEDURES ............................................................................................................ 11 TESTING WITH A BLOOD SAMPLE ........................................................................................12 Offline measurement modeïŒ(not using iOS device) .............................................................12 Apply the Test Strip ......................................................................................................... 12 Obtaining a Blood Sample ............................................................................................... 12 Apply Your Blood Sample ................................................................................................ 12 Read the Test Results ...................................................................................................... 12 Discard the Used Test Strips ............................................................................................ 12 Discard the Used Lancet .................................................................................................. 13 Online measurement modeïŒ(with iOS device) .....................................................................13 Apply the Test Strip ......................................................................................................... 13 Obtaining a Blood Sample ............................................................................................... 13 Apply Your Blood Sample ................................................................................................ 13 Read the Test Results ...................................................................................................... 14 Discard the Used Test Strips ............................................................................................ 14 Discard the Used Lancet .................................................................................................. 14 Control Solution ............................................................................................................................14 Page 2 of 27 Performing an Offline Control Solution Test with Meter Alone (not using iOS device) ........15 I Performing an Online Control Solution Test (with iOS device) ...........................................16 IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS...............................17 METER MEMORY ........................................................................................................................17 Offline measurement modeïŒ(not using iOS device) .............................................................17 Reviewing Test Results .................................................................................................... 17 Online measurement modeïŒ(with iOS device) .....................................................................18 REFERENCE VALUE OF THE IHEALTH WIRELESS SMART GLUCOSE METER.........18 COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS ....18 Before Going to the Lab .........................................................................................................19 While at the Lab......................................................................................................................19 Cleaning and Disinfection...............................................................................................................19 IHEALTH WIRELESS SMART GLUCO-MONITORING SYSTEM SPECIFICATIONS......21 Maintenance and Storage of your Wireless SMART GLUCOSE METER...........................21 LIMITATIONS OF USE ................................................................................................................22 SYSTEM TROUBLE SHOOTING ..............................................................................................23 Result Readings ......................................................................................................................23 Error Message ............âŠ
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PrÃŒfbericht - Nr.: Test Report No.: 15058197 001 1. Photographs of EUT Photograph 1: PrÃŒfbericht - Nr.: Test Report No.: 15058197 001
PrÃŒfbericht - Nr.: Test Report No.: 15058197 001 1. Photographs of EUT Photograph 1: PrÃŒfbericht - Nr.: Test Report No.: 15058197 001 Photograph 2:
Produkte Products RF Exposure Statement: Page 1 of 1 Client: ANDON HEALTH CO.,LTD No. 3 Jinping Road, Ya An Street Nankai District Tianjin P.R. China Test item: iHealth Wireless Smart Gluco-Monitoring System Identification: BG5 FCC ID : ZRYBG5 FCC Requirement According to FCC 2.1091, mobile equipment must comply with the following applicable limit for maximum permissible exposure (MPE) specified in FCC 1.1310: Equipment Use Frequency Range Power Density [mW/cm 2 ] Average Time [min] General Population / Uncontrolled Exposure 1.5 â 100GHz 1 6 IC Requirement According to RSS-102 (Issue 4), clause 2.5.2, no routine RF exposure evaluation is required if the transmitter power (e.i.r.p.) is below the following threshold: Frequency Range SAR Limitation [W] Above 1.5GHz 5 Measurement Result The maximum measured transmitter power is the following: Conducted Output Power P out [mW] Maximum Antenna Gain [dBi] P out EIRP [mW] Power Density at 20cm [mW/cm 2 ] 1.05 2.45 0.24 55 0.00036 Note: The power density S in mW/cm 2 is calculated according to the Friis formula: S = (P S = power density in mW/cm 2 P out = antenna conducted output power in mW G = antenna gain in linear scale (here: 2.45dBi=10log(G)) D = distance between observation point and radiating structure in cm (here: 20cm) out · G) / (4Ï Â· D 2 ), where Conclusion The device complies with the FCC and IC RF exposure requirements since the maximum transmitter power density is below the FCC limit and the e.i.r.p. power is below the IC RF exposure evaluation exemption threshold. Refer to test repo rt 15058197 001 for more details. TÃV Rheinland (Shanghai) Co., Ltd. 10-15/F, Huatsing Building, No.88, Lane 777, Guangzhong Road West, Shanghai 200072, P.R. China
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PrÃŒfbericht - Nr.: Test Report No.: 15058197 001 1. Photographs of the Test Setup Photograph 1: Set-up for Radiated Emission, 30MHz-1000MHz PrÃŒfbericht - Nr.: Test Report No.: 15058197 001 Photograph 2: Set-up for Radiated Emission, 1G-18GHz Photograph 3: Set-up for Conduct Power
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 2.40 GHz - 2.48 GHz | 1.00 mW |

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