OXJTE40Smart Ear Thermometer

Smart Ear Thermometer Simple Operation High Measuring Accuracy USER MANUAL 1 English NantCare LLC, 2929 N 44th Street Phoenix, Arizona, 85018-7239 - USA 1-855-NANTCARE - Email: [email protected] www.nantcare.com Copyright© Revision 07 2012 Smart Ear Thermometer 2 2 NantCare LLC, 2929 N 44th Street Phoenix, Arizona, 85018-7239 - USA 1-855-NANTCARE - Email: [email protected] www.nantcare.com Table of Contents 1 Table of Contents 1.1 Introduction P 4 1.2 Intended Use P 4 1.3 Safety Information P 5 1.3.1 Warnings P 7 1.3.2 Cautions P 8 1.4 Before taking a measurement P 9 2 Operating Instructions P 11 2.1 Know your Ear Thermometer P 11 2.2 Unit Display P 12 2.3 Display Symbols P 13 2.4 Batteries Installation P 14 2.5 Batteries Replacement P 15 2.6 Using the Ear Thermometer P 16 2.6.1 Menu Setting P 16 2.7 Taking a Measurement P 17 2.8 Bluetooth activation & pairing P 18 2.8.1 Pairing for smart phone/tablet P 18 2.8.2 Pairing with the HBox® P 18 2.9 Data Transmission P 19 2.10 Using the software P 19 2.11 Evaluation by a care provider P 21 3 Care and Maintenance P 21 3.1 Cleaning P 21 3.2 Maintenance P 21 4 Troubleshooting P 22 4.1 Error Indicator P 22 4.2 Troubleshooting Tips P 22 5 FCC Statement P 23 6 CE mark P 26 7 Warranty P 27 8 Specifications P 30 9 Manufacturer P 32 3 Thank you for choosing the NantLife Smart Ear Thermometer. This innovative medical device relies on advanced infrared (IR) technology to measure temperature instantly. Your new digital thermometer uses the infrared heat generated by the eardrum and its surrounding tissue. The thermometer then converts it into a tem- perature value displayed on the OLED screen. Note: The thermometer does not emit any infrared signal. Measured values are transmitted automatically to a database via a Bluetooth-en- abled mobile phone and/or the HBox® hub. Choose between 2 basic configurations: 1) Smart Medical Home with NantLife HBox® 2) Mobile Health with your Bluetooth-enabled smartphone or tablet The NantLife Smart Pulse Oximeter comes with the following components: • Color OLED screen display (organic light-emitting diode) • Uni-size Finger probe • Real-time and non real-time Bluetooth® data transmission • Real-time inner clock (for transmission only, not for display) • User Manual • User Guide 1.1 Introduction 4 English • NantLife Smart Ear Thermometer is intended for home monitoring of body temperature. • The NantLife Smart Ear Thermometer is not intended to be a diagnostic device. • Never change your medication on the basis of results you have obtained. The evaluation of the measurements and the treatment based on them may only be carried out by the treating physician. • This device is intended for use in measuring body temperature in the adult and pediatric population. Do not use this device in infants or person who cannot express their intention. 1.3 Safety Information To assure the correct use of the thermometer, basic safety measures should always be followed including the warnings and cautions lifted in this instruction manual. 1.2 Intended Use 5 1.3.1 Warnings Read all of the information in the instruction manual and any other instruction in the box before operating the thermometer. If you experience discomfort during a measurement- Remove the probe from your ear canal and stop using the device. Please contact NantLife Customer Service. In addition, please note: • Proper technique is crucial to getting accurate temperature readings. Please read this manual carefully before using the device. • Basic safety precautions should always be observed, especially when the thermometer is used on or near children and disabled persons. • Temperature of left and right ear may differ. Always measure using the same ear. • Do not under any circumstances use the device in the bath or the shower. If, however, liquid get into the device, you must remove the batteries im- mediately and refrain from further use. Contact our service department (see front cover). • The device may not be used near a nuclear magnetic tomographic resonance. • Using components that are not part of the scope of delivery can produce faulty measurements (Exception: battery replacement). • DO NOT subject the monitor to strong shocks such as dropping it on the floor. 6 English • DO NOT damage the batteries. If battery fluid gets in your eyes, immediately rinse with plenty of clean water and contact a physician immediately. • Keep away from source of fire and/or heat. • Store the device in a clean, safe location. • DO NOT disassemble the ear thermometer. • DO NOT use the ear thermometer in a MRI or CT environment. • DO NOT use the ear thermometer in the presence of flammable anesthetics. • Explosion hazard: Do not use the ear thermometer in an explosive atmosphere. • Chemicals from OLED panel are toxic if ingested. Use caution if the ear ther- mometer display screen is broken. • The ear thermometer is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. • Prolonged use or the patient’s condition may require changing the ear pe- riodically. • Use only 1.5V alkaline batteries with this device. Other type of battery may damage the unit. • Follow local ordinances and recycling instructions regarding disposal or recy- cling of the device components, including batteries. • Only the authorized service personnel can repair this device. 7 1.3.2 Cautions • Autoclaving, ethylene oxide sterilizing, or immersing the ear thermometer in liquid may cause inaccurate measurements. • The accuracy cannot be ensured for a person who has deformity in the ear. The thermometer probe cannot be inserted properly into the ear canal. NantLife suggests the use of its Contactless Forehead Thermometer in that case. • Blood or drainage in the ear may affect accuracy. • Do not use an ear if ear drops or medication have been placed. • For users with ear plug and/or earing aid, remove the device and wait 15 minutes bef…

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PHOTOGRAPHS OF THE EUT Whole View of EUT Open View of EUT Top View of EUT Button View of EUT Front of EUT Back View of EUT Left View of EUT Right View of EUT

Smart Ear Thermometer Model Name：TE4.0 Brand Name：NantLife FCC ID: OXJTE40

Open View of EUT Internal View-1 of EUT Internal View-2 of EUT Internal View-3 of EUT Bluetooth antenna Internal View-4 of EUT

FCC Test Report Report No.: AGC026120602‐2F2B FCC ID : OXJTE40 IC : 10549A‐TE40 PRODUCT DESIGNATION : Smart Ear Thermometer BRAND NAME : NantLife TEST MODEL : TE4.0 CLIENT : NantCare LLC DATE OF ISSUE : Sep.13, 2012 STANDARD(S) : FCC Part 15 Rules& RSS‐210 Attestation of Global Compliance (Shenzhen) Co., Ltd. CAUTION: This report shall not be reproduced except in full without the written permission of the test laboratory and shall not be quoted out of context. Report No.: AGC026120602-2F2B Page 1 of 27 TABLE OF CONTENTS 1. VERIFICATION OF COMPLIANCE ··············································································································· 3 2. GENERAL INFORMATION ···························································································································· 4 2.1. PRODUCT DESCRIPTION FOR EQUIPMENT UNDER TEST (EUT) ······················································· 4 2.2. TEST STANDARDS ································································································································ 4 2.3. RELATED SUBMITTAL(S)/GRANT(S) ···································································································· 4 2.4. TEST METHODOLOGY ·························································································································· 5 2.5. TEST FACILITY ······································································································································· 5 2.6. ACCESSORIES EQUIPMENT LIST AND DETAILS ················································································ 5 2.7. EUT PORT&CABLE LIST AND DETAILS ································································································ 5 3. SUMMARY OF TEST RESULTS ··················································································································· 6 4. TEST MODES ················································································································································ 6 5. §15.203 - ANTENNA REQUIREMENT ·········································································································· 7 5.1. STANDARD APPLICABLE ······················································································································ 7 5.2. TEST RESULT ········································································································································ 7 6. §15.209, §15.249 RADIATED EMISSION ······································································································ 8 6.1. MEASUREMENT UNCERTAINTY ·········································································································· 8 6.2. STANDARD APPLICABLE ······················································································································ 8 6.3. TEST EQUIPMENT LIST AND DETAILS································································································· 9 6.4. TEST PROCEDURE ······························································································································· 9 6.5. TEST SET-UP (BLOCK DIAGRAM OF CONFIGURATION) ································································· 10 6.6. TEST RESULTS ···································································································································· 12 7. §15.249 EMISSION BANDWIDTH ··············································································································· 17 7.1. STANDARD APPLICABLE ···················································································································· 17 7.2. TEST EQUIPMENT LIST AND DETAILS······························································································· 17 7.3. TEST PROCEDURE ····························································································································· 17 7.4. SUMMARY OF TEST RESULTS/PLOTS ······························································································ 17 Report No.: AGC026120602-2F2B Page 2 of 27 APPENDIX 1 ···················································································································································· 20 PHOTOGRAPHS OF TEST SETUP ················································································································ 20 APPENDIX 2 ···················································································································································· 21 PHOTOGRAPHS OF EUT ······························································································································· 21 Report No.: AGC026120602-2F2B Page 3 of 27 1. VERIFICATION OF COMPLIANCE Applicant: NantCare LLC Applicant Address: 2929 N. 44th Street, Suite 110 Phoenix, AZ 85018 Manufacturer: Shenzhen Jian Lang Technology Co., Ltd Manufacturer Address: 202,2F,Block 1,Nanyou Tian'an Industry Town SZ.R.P.C Product Description: Smart Ear Thermometer Brand Name: NantLife Model Name: TE4.0 FCC ID: OXJTE40 IC 10549A-TE40 Report Number: AGC026120602-2F2F2B Date of Test: Aug.20,2012 to Aug.27,2012 WE HEREBY CERTIFY THAT: The above equipment was tested by Attestation of Global Compliance (Shenzhen) Co., Ltd. The test data, data evaluation, test procedures, and equipment configurations shown in this report were made in accordance with the procedures given in ANSI C63.4 (2003) and the energy emitted by the sample EUT tested as described in this report is in compliance with radiated emission limits of FCC Rules Part 15.249. Tested By : Huang Wall Sep.13, 2012 Review By : Forrest Lei Sep.13, 2012 Approved By: Solger Zhang Sep.13, 2012 Report No.: AGC026120602-2F2B Page 4 of 27 2. GENERAL INFORMATION 2.1. PRODUCT DE…

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PHOTOGRAPHS OF THE TEST SETUP RADIATED SPURIOUS EMISSION