OXJOF40Smart Pulse Oximeter

Smart Pulse Oximeter 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 Pulse Oximeter 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 5 1.3 Safety Information P 5-8 1.3.1 Operating the device P 6 1.3.1.1 Warnings P 6 1.3.1.2 Cautions P 8 1.4 Before taking a measurement P 9 2 Operating Instructions P 11 2.1 Know your Pulse Oximeter 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 Pulse Oximeter P 16 2.7 Taking a Measurement P 17 2.8 Menu Setting P 18 2.9 Bluetooth activation & pairing P 20 2.9.1 Pairing for smart phone/tablet P 20 2.9.2 Pairing with the HBox® P 20 2.10 Data Transmission P 21 2.11 Using the software P 21 2.12 Evaluation by a care provider P 23 3 Care and Maintenance P 23 3.1 Cleaning P 23 3.2 Maintenance P 23 4 Troubleshooting P 24 4.1 Error Indicator P 24 4.2 Troubleshooting Tips P 25 5 FCC Statement P 26 6 CE mark P 29 7 Warranty P 30 8 Specifications P 32 9 Manufacturer P 34 3 Thank you for purchasing the NantLife Pulse Oximeter. With its unique wireless integrated technology, the NantLife Smart Pulse Oximeter enables you to perform first-class, comfortable and extremely gentle non-invasive measurements of the oxygenation of a user’s hemoglobin. You have chosen the most up-to-date form of healthcare management. Measured values are transmitted automatically to a data- base via a Bluetooth-enabled 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 • Interval Bluetooth® data transmission • Real-time inner clock (for transmission only, not for display) • User Manual • User Guide • Warranty card 1.1 Introduction 4 English The fingertip NantLife Smart Pulse Oximeter is for the home use. • NantLife Smart Pulse Oximeter is intended for spot-checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate in the home. • It is intended for adult and pediatric patients on finger between 0.3-1.0inch (0.8-2.5cm) thick. • Never change your medication on the basis of results you have obtained. The treating physician may only carry out the evaluation of the measure- ments and the treatment based on them. • The NantLife Smart Pulse Oximeter is not intended to be a diagnostic device. • This device is intended for use in measuring oxygen saturation in blood pres- sure and pulse rate 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 pulse oximeter, basic safety measures should always be followed including the warnings and cautions lifted in this instruction manual. 1.2 Intended Use 5 1.3.1.1 Warnings Read all of the information in the instruction manual and any other instruction in the box before operating the unit. If you experience discomfort during a measure- ment, open the clamp and remove immediately your finger from the device. Stop using the device, turn it off and please contact NantLife Customer Service. In addition, please note: • Self-diagnosis and treatment using measured results may be dangerous. Fol- low the instructions of your physician or licensed healthcare provider. • 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 the unit on the floor. • 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. 6 English • Store the device in a clean, safe location. • DO NOT disassemble the Smart Pulse Oximeter. • DO NOT use the Smart Pulse Oximeter in a MRI or CT environment. • DO NOT use the Pulse Oximeter in the presence of flammable anesthetics. • Explosion Hazard: DO NOT use the Smart Pulse Oximeter in an explosive at- mosphere. • Chemicals from OLED panel are toxic if ingested. Use caution if the blood pressure meter display screen is broken. • The Smart Pulse Oximeter is intended only as an adjunct in patient assess- ment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. • Check the Pulse Oximeter application site frequently to determine skin sen- sitivity of the patient. • Prolonged use or the patient’s condition may require changing the site peri- odically. Change finger and check skin integrity, circulatory status. • 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 1.3.1.2 Cautions • Significant levels of dysfunctional hemoglobin may cause inaccurate readings. • Measurements may be affected by dyes such as indocyanine green and methylene blue. • Measurements may be affected by upper ambient light (e.g. direct sunlight). • Excessive user movement may cause inaccuracy. …

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PHOTOGRAPHS OF THE 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 Pulse Oximeter Model Name：OF4.0 Brand Name：NantLife FCC ID: OXJOF40

Open View of EUT-1 Internal View of EUT-1 Internal View of EUT-2 Internal View of EUT-3 Bluetooth Antenna

FCC Test Report Report No.: AGC026120602‐3F2B FCC ID : OXJOF40 IC : 10549A‐OF40 PRODUCT DESIGNATION : Smart Pulse Oximeter BRAND NAME : NantLife TEST MODEL : OF4.0 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.: AGC026120602-3F2B Page 1 of 25 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.: AGC026120602-3F2B Page 2 of 25 APPENDIX 1 ···················································································································································· 20 PHOTOGRAPHS OF TEST SETUP ················································································································ 20 APPENDIX 2 ···················································································································································· 21 PHOTOGRAPHS OF EUT ······························································································································· 21 Report No.: AGC026120602-3F2B Page 3 of 25 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 Pulse Oximeter Brand Name: NantLife Model Name: OF4.0 FCC ID: OXJOF40 IC 10549A-OF40 Report Number: AGC026120602-3F2F2B 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 : Bart Xie Sep.13, 2012 Review By : Forrest Lei Sep.13, 2012 Approved By: Solger Zhang Sep.13, 2012 Report No.: AGC026120602-3F2B Page 4 of 25 2. GENERAL INFORMATION 2.1. PRODUCT DESCRI…

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PHOTOGRAPHS OF THE TEST SETUP RADIATED SPURIOUS EMISSION