ZRYBG5LiHealth Wireless Smart Gluco-Monitoring System

Page 1 of 25 For in vitro diagnostic use only Read instructions before use For self-testing iHealth TM Wireless Smart Gluco‐Monitoring System (BG5L) OWNER’S MANUAL Table of Contents INTRODUCTIN ............................................................................................................................... 3 PACKAGE CONTENTS................................................................................................................. 3 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) ............................................. 7 What is Alternate Site Testing? ................................................................................................. 7 What is the Advantage of Alternative Site Testing? ................................................................. 8 When to Use Alternative Site Testing? ..................................................................................... 8 PARTS AND DISPLAY INDICATORS ......................................................................................... 9 Glucose Meter ........................................................................................................................... 9 Blood Glucose Test Strip ......................................................................................................... 10 SETUP PROCEDURES ............................................................................................................ 11 TESTING WITH A BLOOD SAMPLE ........................................................................................ 12 Offline measurement mode：(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 mode：(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 25 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 mode：(not using iOS device) ............................................................. 17 Reviewing Test Results .................................................................................................... 17 Online measurement mode：(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 IHEALTH WIRELESS SMART GLUCO-MONITORING SYSTEM SPECIFICATIONS ...... 19 Maintenance and Storage of your Wireless SMART GLUCOSE METER ........................... 20 LIMITATIONS OF USE ................................................................................................................ 20 SYSTEM TROUBLE SHOOTING .............................................................................................. 21 Result Readings ...................................................................................................................... 21 Error Message .............................................................................................................…

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Prüfbericht - Nr.: Test Report No.: 15060973 001 1. Photographs of EUT Photograph 1: Prüfbericht - Nr.: Test Report No.: 15060973 001

Prüfbericht - Nr.: Test Report No.: 15060973 001 1. Photographs of EUT Photograph 1: Prüfbericht - Nr.: Test Report No.: 15060973 001 Photograph 2: Prüfbericht - Nr.: Test Report No.: 15060973 001

Produkte Products FCC ID: ZRY-BG5L Seite 1 von 1 Page 1 of 1 1. Safety Human exposure 1.1 Radio Frequency Exposure Compliance 1.1.1 Electromagnetic Fields RESULT: Passed Test standard : FCC KDB Publication 447498 10 D01v05 According to KDB447498 10 D01v05: SAR evaluation, by measurement or numerical simulation, is not required when the corresponding SAR Exclusion Threshold condition, listed below, is satisfied. The enclosure of the device provides ≥ 2.5 cm separation from the antenna elements to significant metal parts of the enclosure to minimize potential perturbations. Frequency Band: 2400-2483.5 MHz Maximum Power fed to Antenna: 2.29 mW Separation distances: Antenna feed center to metal parts of enclosure: N/A Antenna feed center to outside surface of enclosure: > 2.5 mm Distance prescribed in user manual: > 0 mm Distance used for evaluation: > 2.5 mm MHz 2.5 5 10 15 20 25 mm 2450 4.8 10 19 29 38 48 SAR Test Exclusion Threshold (mW) MHz 30 35 40 45 50 mm 2450 57 67 77 86 96 SAR Test Exclusion Threshold (mW) MHz 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 mm 2450 96 196 296 396 496 596 696 796 896 996 1096 1196 1296 1396 1496 mW

TÜV Rheinland LGA Products  Tillystrasse 2  D-90431 Nürnberg  Tel.: +49 911 655 5225  Fax +49 911 655 5226 Mail: [email protected]  Web: www.tuv.com QMA TRLP 6.1-350 Version: 1 01.08.2011 Produkte Products Prüfbericht - Nr.: 15060973 001 Test Report No.: Seite 1 von 37 Page 1 of 37 Auftraggeber: Client: Andon Health Co.,Ltd No. 3 Jinping Road, Ya An Street ,Nankai District ,TianJin China Gegenstand der Prüfung: Test item: iHealth Wireless Smart Gluco-Monitoring System Bezeichnung: Identification: BG5L FCC ID :ZRYBG5L IC: 9775A-BG5L Serien-Nr.: Serial No.: N/A Wareneingangs-Nr.: Receipt No.: 154018127 Eingangsdatum: Date of receipt: 2013.3.1 Zustand des Prüfgegenstandes bei Anlieferung: Condition of test item at delivery: Test sample(s) is/are not damaged and suitable for testing. Prüfort: Testing location:  TÜV Rheinland (Shanghai) Co., Ltd.  QuieTek Technology(Suzhou)Co., Ltd. (Detailed address refer to clause 2.1) Prüfgrundlage: Test specification: FCC 47 CFR Part 15, Subpart C, §15.247 ANSI C63.4-2009 ANSI C63.10-2009 KDB 558074 D01 DTS Meas Guidance v02 Prüfergebnis: Test Result: Der Prüfgegenstand entspricht oben genannter Prüfgrundlage(n). The test item passed the test specification(s). Prüflaboratorium: Testing Laboratory: TÜV Rheinland (Shanghai) Co., Ltd. Building 2, No. 777 Guangzhong Road West, Shanghai 200072, P.R. China geprüft/ tested by: 2013-05-29 Shili / Inspector kontrolliert/ reviewed by: 2013-05-29 Jesse Huang / Reviewer Datum Date Name/Stellung Name/Position Unterschrift Signature Datum Date Name/Stellung Name/Position Unterschrift Signature Sonstiges/ Other Aspects: Abkürzungen: P(ass) = entspricht Prüfgrundlage F(ail) = entspricht nicht Prüfgrundlage N/A = nicht anwendbar N/T = nicht getestet Abbreviations: P(ass) = passed F(ail) = failed N/A = not applicable N/T = not tested Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfmuster und darf ohne Genehmigung der Prüfstelle nicht auszugsweise vervielfältigt werden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens. This test report relates to the a. m. test item. Without permission of the test center this test report is not permitted to be duplicated in extracts. This test report does not entitle to carry any safety mark on this or similar products. Produkte Products Prüfbericht - Nr.: Test Report No.: 15060973 001 Seite 2 von 37 Page 2 of 37 TEST SUMMARY 3.2.1 VOLTAGE REQUIREMENTS, FCC 15.31(E) RESULT: PASS 3.2.2 ANTENNA REQUIREMENTS, FCC 15.203, FCC 15.204 AND RSS-GEN 7.1.4 RESULT: PASS 5.1.1 CONDUCTED OUTPUT POWER, FCC 15.247(B)(3) AND RSS-210 A8.4(2) RESULT: PASS 5.1.2 6DB&99% BANDWIDTH, FCC 15.247(A)(2) AND RSS-210 A8.2(A) 5.1.3 POWER SPECTRAL DENSITY (PSD), FCC 15.247(E) AND RSS-210 A8.2 RESULT: PASS 5.1.4 CONDUCTED SPURIOUS EMISSION, FCC 15.247(D) AND RSS-210 A8.5 RESULT: PASS 5.1.5 BAND EDGE COMPLIANCE OF RF CONDUCTED EMISSION, FCC 15.247(D) AND RSS-210 A8.5 RESULT: PASS 6.1.1 BAND EDGE RADIATED EMISSION, FCC 15.205, FCC 15.209, FCC 15.247(D), RSS-210 2.2, RSS-210 2.6 AND RSS-210 A8.5 RESULT: Pass 6.1.2 RADIATED SPURIOUS EMISSION OF TRANSMITTER, FCC 15.205, FCC 15.209, FCC 15.247(D), RSS-210 2.2, RSS-210 2.6 AND RSS-210 A8.5 RESULT: PASS 6.2.1 RADIATED SPURIOUS EMISSION OF RECEIVER, FCC 15.109, RSS-210 2.2, RSS- 210 2.6, RSS-210 A8.5, RSS-GEN 7.2.3.2 RESULT: PASS Produkte Products Prüfbericht - Nr.: Test Report No.: 15060973 001 Seite 3 von 37 Page 3 of 37 CONTENTS 1. GENERAL REMARKS ............................................................................................... 5 1.1 COMPLEMENTARY MATERIALS ................................................................................. 5 2. TEST SITES ............................................................................................................ 5 2.1 TEST FACILITIES ..................................................................................................... 5 2.2 LIST OF TEST AND MEASUREMENT INSTRUMENTS ...................................................... 6 2.3 MEASUREMENT UNCERTAINTY ................................................................................. 6 3. GENERAL PRODUCT INFORMATION ........................................................................... 7 3.1 PRODUCT FUNCTION AND INTENDED USE .................................................................. 7 3.2 SYSTEM DETAILS .................................................................................................... 7 3.2.1 Voltage Requirements, FCC 15.31(e).......................................................................................... 7 3.2.2 Antenna Requirements, FCC 15.203, FCC 15.204 and RSS-Gen 7.1.4 ..................................... 7 3.3 INDEPENDENT OPERATION MODES ........................................................................... 8 3.4 NOISE SUPPRESSING PARTS .................................................................................... 8 4. TEST SET-UP AND OPERATION MODES ..................................................................... 9 4.1 TEST METHODOLOGY .............................................................................................. 9 4.2 PHYSICAL CONFIGURATION FOR TESTING ................................................................. 9 4.3 TEST OPERATION AND TEST SOFTWARE ................................................................... 9 4.4 SPECIAL ACCESSORIES AND AUXILIARY EQUIPMENT ................................................. 9 4.5 COUNTERMEASURES TO ACHIEVE EMC COMPLIANCE ................................................ 9 5. TEST RESULTS OF CONDUCTED MEASUREMENTS AT ANTENNA PORT ....................... 10 5.1 TRANSMITTER PARAMETERS .................................................................................. 10 5.1.1 Conducted Output Power, FCC 15.247(b)(3) and RSS-210 A8.4(2) ......................................... 10 5.1.2 6dB&99% Bandwidth, FCC 15.247(a)(2) and RSS-210 A8.2(a) ............................................... 12 5.1.3 Power…

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Prüfbericht - Nr.: Test Report No.: 15060973 001 1. Photographs of the Test Setup Photograph 1: Set-up for Radiated Emission, 30MHz-1000MHz Prüfbericht - Nr.: Test Report No.: 15060973 001 Photograph 2: Set-up for Radiated Emission, 1G-18GHz Photograph 3: Set-up for Conduct Power