2AU9T-CART1CCART-I

F401-01(A-190102) Sky Labs Inc. Instructions for use(IFU)(CART-I) Sky Labs Inc. #703, C's tower, 58, Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea F401-01(A-190102) Sky Labs Inc. ◆ Approval Author Review Review Review Review Dept. Name or Position R&D RA BD manager R&D manager CEO Name Sungmi Jo Kyungeun Yoo Yumi Ji Changhyun Baik Byunghwan Lee Signature Date ◆ Revision information No. Date Description Remark 0 2019.05.24 Initial release 1 2019.12.18 Corrective action of 1 st MTIC review & add the FCC requirements F401-01(A-190102) Sky Labs Inc. ◆ 목 차(Contents) Chapter Contents Remark 1 Device description & Intended use 2 Packages 3 Device specification 4 Environment specification 5 Symbols 6 Safety Precautions 7 Contraindications 8 Disposal 9 Warranty 10 Installation & Charging 11 Operation 12 Information on EMC 14 FCC Compliance state 15 Troubleshooting F401-01(A-190102) Sky Labs Inc. Instruction For Use CART-I by Sky Labs Inc. Thank you for choosing CART-I. Please read this Instruction for use, including all Precautionary information and instructions, before using your device. Failure to follow the instructions below could result in device damage or malfunction, or even injury. The issue date for IF-01(revision 1) is December 2019. If more than three years have elapsed since this date, contact Sky Labs Inc. to determine if additional device information updates are available. If you have any questions about using your device or mobile app, please contact Sky Labs Inc. Sky Labs Inc. #703, 58, Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea www.i-skylabs.com Tel: +82-31-8092-3290 CE Medical Amerlandseweg 7, 3621ZC, Breukelen, the Netherlands IF-01(revision 1) Dec 2019 F401-01(A-190102) Sky Labs Inc. CHAPTER 1. Device description & Intended use CART-I consists of devices, including CART-Ring and CART-Cradle, CART-App(Mobile Application) for general users, and CART-Web(website) for doctors. CART-I provides photoplethysmography(PPG) signals to measure heart rate(HR) and to identify Atrial Fibrillation or its burden, and electrocardiogram(ECG) signals to offer supplementary information to doctors. A part of CART-I, CART-Ring is a ring-type wearable device, which collects(or records), stores, and transfers not only PPG signals but also single-channel ECG signals. CART-Ring operates continuously to collect only PPG signals - referred to as "Background-Check" within this submission -without user intervention, while collecting both PPG and ECG signals - referred to as "Self-Check" within this submission -by users' intention. Inside of CART-Ring, a Lithium Polymer battery can be recharged using CART-Cradle, operating based on the wireless charging technique. CART-I utilizes an iOS-based CART-App, which is installed on an iPhone, to obtain PPG and ECG signals from CART-Ring. After obtaining both signals, CART-App transmits those signals to a cloud server to get results, such as an estimation of HR and an analysis of Atrial Fibrillation or not. CART-App offers the statistics, including the number of checks, the analyzed results, and etc., with graphs and lists to users; Data offered to users are synchronized to their own account. After connecting to users, doctors get more detailed information from a cloud server for their connected users than those for general users using CART-Web. CHAPTER 2. Packages NOT including the mobile phone to install the application, CART-app and adapter . You’ll additionally need the followings to operate the device of Sky Labs Inc.  mobile phone : >iPhone 6, >iOS10.0, BLE(BT 5.0)  CART-App is available in the Apple App Store. F401-01(A-190102) Sky Labs Inc. CHAPTER 3. Device specification 1. Product name : Heart Monitor 2. Trade name / Model name : CART-I 3. Model Number Model number of full packages(set) Model number of CART-Ring Model number of CART-Cradle A0K1 R0K1 C0K1 A0K2 R0K2 C0K2 A0K3 R0K3 C0K3 A0K4 R0K4 C0K4 A0K5 R0K5 C0K5 A0K6 R0K6 C0K6 A0K7 R0K7 C0K7 A0K8 R0K8 C0K8 4. Intended use CART-I is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation or its burden and who would like to monitor and record their heart rhythms and heart rates on an intermittent or continuous basis. CART-I is intended to be used in the home-healthcare environment. 5. General information Part Feature CART-Ring Rated Power Internally Powered, Lithium polymer battery, 3.7 Vd.c. Max power(R0K1) -4 dBm(Burst Average power) BT frequency Charging frequency : 205kHz Operating frequency : 2402-2480MHz IP Grade IP58 Temperature -20°C ~ 50°C Mode of operation Continuous Protection against electric shock Grade II / Internally Powered, BF type applied part, Body-worn RF specification Bluetooth Low Energy, Bluetooth 5.0, distance: <2m Firmware Ver.1.0.0 CART-Cradle Rated Power 5Vd.c. Rated Power Consumption 50mW~5W Charging method Wireless Charging / Operating Frequency < 205kHz / Magnetic Inductive / using USB cable CART-App Ver. 1.0.0 Language : English 6. Applied part Inner metal, sensor and outer of CART-Ring 7. Product life time CART-I is guaranteed to last for a minimum of 2 years. F401-01(A-190102) Sky Labs Inc. CHAPTER 4. Environment specification Item Description Operating & Charging Temperature 5°C~45°C Operating & Charging Humidity 10%~95% Storage/Transport Temperature -25°C to 70°C Storage/Transport Humidity 10%~95% Operating & Storage/Transport Atmospheric Pressure 700hPa to 1060hPa CHAPTER 5. Symbols 1. Box symbols Fragile, handle with care Keep dry Limitation for Transport and storage 2. Device Symbols Manufacturer information CE marking of conformity Serial number Temperature limitation Type BF Humidity limitation Date of manufacture Atmospheric pressure limitation Refer to the Instruction for use Manufacturer’s EU Representative information F401-01(A-190102) Sky Labs Inc. IP Grade Do not dispose with household waste Direct current 3. IFU Symbols Warning : Indicates a potenti…

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Sky Labs Inc. #703, 58, Pangyo-ro 255beon-gil Bundang-gu, Seongnam-si Gyeonggi-do South Korea Date: 02/06/2020 Timco Engineering, Inc. 849 N.W. State Road 45 P.O. Box 370 Newberry, Florida 32669 USA Letter of Authorization We, the undersigned, hereby authorize Guenki Son of DT&C Co., Ltd. to act on our behalf in all manners relating to application for equipment authorization for FCC ID: 2AU9T-CART1C including signing of all documents relating to these matters. Any and all acts carried out by Guenki Son of DT&C Co., Ltd. on our behalf shall have the same affect as acts of our own. This authorization is valid until further written notice from Sky Labs Inc. “I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a).” Sincerely, Jack Lee CEO

Sky Labs Inc. #703, 58, Pangyo-ro 255beon-gil Bundang-gu, Seongnam-si Gyeonggi-do South Korea Date: Feb 06, 2020 Timco Engineering, Inc. 849 N.W. State Road 45 P.O. Box 370 Newberry, Florida 32669 USA RE: Request of Confidentiality for FCC ID: 2AU9T-CART1C To Whom It may Concern: Pursuant to Sections 0.457 and 0.459 of the Commission`s Rules(CFR 47), and Section 552 (b) (4) of the Freedom of Information Act, Sky Labs Inc. hereby requests confidentiality and treatment of certain information accompanying this application. The materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. We are also hereby request Short-Term Confidentiality for 180 days after the grant as outlined in Public Notice DA 04-1705. This provision will give Sky Labs Inc. temporary confidentiality of commercially sensitive information prior to product release. The requested permanent and Short-Term Confidential exhibits are listed as follows: PERMANENT & SHORT-TERM CONFIDENTIAL LIST Exhibit Description PERMANENT 1 Block Diagram 2 Schematics 3 Part Lists 4 Operation Description SHORT-TERM 5 Internal Photos 6 External Photos 7 Test-Setup Photos 8 User Manual The Applicant understands that pursuant to Rule 0.457, disclosure of this application and all accompanying documentations, where applicable, will not be public before the date of the Grant for this application. Sincerely, Jack Lee CEO

FCC ID: 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. View 1 FCC ID: 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. View 2 FCC ID: 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. View 3 FCC ID: 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. View 4 < USB C-Type>

FCC ID: 2AU9T-CART1C Copyright Ⓒ 2020 DT&C Co., Ltd. SAMPLE LABEL & LOCATION LABELLING REQUIREMENTS The Label shown shall be permanently affixed at a conspicuous location on the device and be readily visible to the user at the time of purchase. - The FCC label shown is representative of the label that will appear on the radio when in production. Other information may also be included on this label.

FCC ID: 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. View 1 FCC ID: 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. View 2 FCC ID: 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. View 3 <ANT>

Report No.: DRTFCC2002-0032 FCC ID: 2AU9T-CART1C TRF-RF-220(04)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 2 / 7 Test Report Version Test Report No. Date Description Tested by Reviewed by DRTFCC2002-0032 Feb. 10, 2020 Initial issue JungWoo Kim JaeJin Lee Report No.: DRTFCC2002-0032 FCC ID: 2AU9T-CART1C TRF-RF-220(04)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 3 / 7 CONTENTS 1. Equipment information ............................................................................ 4 1.1 Equipment description ........................................................................... 4 1.2 Support equipment................................................................................. 4 2. Information about test items ................................................................... 5 2.1 Test Configuration and Mode ................................................................. 5 2.2 Tested environment ................................................................................ 5 3. E and H field strength .............................................................................. 6 Report No.: DRTFCC2002-0032 FCC ID: 2AU9T-CART1C TRF-RF-220(04)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 4 / 7 1. Equipment information 1.1 Equipment description FCC Equipment Class Part 15 Low Power Transmitter Below 1705 kHz (DCD) Equipment type Heart Monitor Equipment model name C0K1 Equipment add model name C0K2, C0K3, C0K4, C0K5, C0K6, C0K7, C0K8 Equipment serial no. Identical prototype Frequency 205 kHz Output power Max : 5 W Power Supply DC 5 V Antenna type Coil Antenna 1.2 Support equipment Product Name FCC ID Manufacturer Note CART-I 2AU9T-CART1R Sky Labs Inc. - - - - - Note: The above equipment was supported by manufacturer. Report No.: DRTFCC2002-0032 FCC ID: 2AU9T-CART1C TRF-RF-220(04)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 5 / 7 2. Information about test items 2.1 Test Configuration and Mode ▪Test configuration The field strength of both E-field and H-field were measured at 15 cm using RF exposure survey meter with E-field and H- field probes for determining compliance with the MPE requirements of FCC Part 1.1310. These testing were performed at test configuration as test setup diagram on clause 3 of this test report. The EUT has been tested together with the client device (FCC ID: 2AU9T-CART1R). During measurements, the EUT was wirelessly charging a battery housed inside a client. The EUT was periodically stopping the test and fully discharging the client devices before resuming the test. This device uses a wireless charging circuit for power transfer operating at the frequency of 205 kHz. Thus, the 300 kHz RF exposure limits were used as below table. ▪ Limit Frequency E-Field limit H-Field limit FCC Part 1.1310 300 kHz ~ 3 MHz 614 V/m 1.63 A/m 2.2 Tested environment Temperature : 23 ~ 25 o C Relative humidity content : 35 ~ 43 % Details of power supply : DC 5 V Report No.: DRTFCC2002-0032 FCC ID: 2AU9T-CART1C TRF-RF-220(04)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 6 / 7 3. E and H field strength For RF exposure purposes, the E and H field strengths are measured separately with E and H probes and meters at different locations surrounding the test setup. ▪ Test setup diagram ▪ Measurement procedure: KDB 680106 These testing were performed at test configuration as above diagram. EUT was placed on a turntable, and the measurement distance of 15 cm from the center of the probe to the edge of the device. And test was performed all sides of the EUT(except bottom side). ▪Measurement data: Test Mode E-field(V/m) Limit(V/m) Front Rear Right Left Top FCC EUT with client 0.36 0.95 0.40 0.32 0.43 614 - - - - - - - - - - - - Test Mode H-field(A/m) Limit(A/m) Front Rear Right Left Top FCC EUT with client 0.090 0.120 0.060 0.060 0.070 1.63 - - - - - - - - - - - - Measurement Distance (15cm) Rear Front Right Top Left Report No.: DRTFCC2002-0032 FCC ID: 2AU9T-CART1C TRF-RF-220(04)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 7 / 7 ▪Test equipment list Type Manufacturer Model Cal.Date (yy/mm/dd) Next. Cal.Date (yy/mm/dd) S/N EMF Meter NARDA ELT-400 18/12/10 19/12/10 N-0342 EMF probe NARDA B-Field Probe 18/12/10 19/12/10 M-0779 Broadband field meter NARDA NBM-550 17/12/27 19/12/27 E-1275 Broadband field probe NARDA EF-0391 17/12/27 19/12/27 D-0894 Thermohygrometer BODYCOM BJ5478 18/12/27 19/12/27 120612-2

Report No.: DRTFCC2002-0033 FCC ID: 2AU9T-CART1C TRF-RF-204(06)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 2 / 16 Test Report Version Test Report No. Date Description Tested by Reviewed by DRTFCC2002-0032 Feb. 10, 2020 Initial issue JungWoo Kim JaeJin Lee Report No.: DRTFCC2002-0033 FCC ID: 2AU9T-CART1C TRF-RF-204(06)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 3 / 16 CONTENTS 1. General Information .................................................................. 4 1.1. Testing Laboratory ................................................................. 4 1.2. Testing Environment .............................................................. 4 1.3. Measurement Uncertainty ..................................................... 4 1.4. Details of Applicant ................................................................ 5 1.5. Description of EUT ................................................................ 5 2. Information about test items .................................................... 6 2.1 Test mode ............................................................................... 6 2.2 Support equipment ................................................................. 6 2.3 EMI Suppression Device(s)/Modifications .............................. 6 3. Antenna requirements .............................................................. 6 4. Test Report ................................................................................ 7 4.1 Summary of tests ................................................................... 7 4.2 Transmitter requirements........................................................ 8 4.2.1 20 dB Bandwidth ................................................................ 8 4.2.2 Radiated Emissions ......................................................... 10 4.2.3 AC Line Conducted Emissions ......................................... 12 APPENDIX I ................................................................................. 15 Report No.: DRTFCC2002-0033 FCC ID: 2AU9T-CART1C TRF-RF-204(06)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 4 / 16 1. General Information 1.1. Testing Laboratory DT&C Co., Ltd. The 3 m test site and conducted measurement facility used to collect the radiated data are located at the 42, Yurim-ro, 154beon-gil, Cheoin-gu, Yongin-si, Gyeonggi-do, Korea 17042. The test site complies with the requirements of § 2.948 according to ANSI C63.4-2014. - FCC MRA Accredited Test Firm No. : KR0034 www.dtnc.net Telephone : + 82-31-321-2664 FAX : + 82-31-321-1664 1.2. Testing Environment Ambient Condition ▪ Temperature 23 °C ~ 25 °C ▪ Relative Humidity 35 % ~ 43 % 1.3. Measurement Uncertainty Test items Measurement uncertainty AC conducted emission 2.4 dB (The confidence level is about 95 %, k = 2) Radiated spurious emission (1 GHz Below) 5.1 dB (The confidence level is about 95 %, k = 2) Report No.: DRTFCC2002-0033 FCC ID: 2AU9T-CART1C TRF-RF-204(06)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 5 / 16 1.4. Details of Applicant Applicant : Sky Labs Inc. Address : #703, 58, Pangyo-ro 255beon-gil Bundang-gu, Seongnam-si Gyeonggi-do South Korea Contact person : Jack Lee 1.5. Description of EUT FCC Equipment Class Part 15 Low Power Transmitter Below 1705 kHz (DCD) Equipment type Heart Monitor Equipment model name C0K1 Equipment add model name C0K2, C0K3, C0K4, C0K5, C0K6, C0K7, C0K8 Equipment serial no. Identical prototype Hardware Version 1.0 Software Version 1.0 Frequency 205 kHz Output power Max : 5 W Power Supply DC 5 V Antenna type Coil Antenna Report No.: DRTFCC2002-0033 FCC ID: 2AU9T-CART1C TRF-RF-204(06)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 6 / 16 2. Information about test items 2.1 Test mode This device has been tested together with the client device (FCC ID: 2AU9T-CART1R). During measurements, the EUT was wirelessly charging a battery housed inside a client. The EUT was periodically stopping the test and fully discharging the client devices before resuming the test. 2.2 Support equipment Product Name FCC ID Manufacturer Note CART-I 2AU9T-CART1R Sky Labs Inc. - - - - - Note: The above equipment was supported by manufacturer. 2.3 EMI Suppression Device(s)/Modifications EMI suppression device(s) added and/or modifications made during testing → None 3. Antenna requirements “An intentional radiator antenna shall be designed to ensure that no antenna other than that furnished by the responsible party can be used with the device. The use of a permanently attached antenna or of an antenna that uses a unique coupling to the intentional radiator shall be considered sufficient to comply with the provisions of this section.” The antenna is permanently attached.(Refer to Internal Photo file.) Therefore this E.U.T Complies with the requirement of §15.203 Report No.: DRTFCC2002-0033 FCC ID: 2AU9T-CART1C TRF-RF-204(06)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 7 / 16 4. Test Report 4.1 Summary of tests FCC Part Section(s) Parameter Limit Test Condition Status Note 1 2.1049 20 dB Bandwidth N/A Radiated C 15.209 Radiated Emission FCC 15.209 limits C 15.207 AC Conducted Emissions FCC 15.207 limits AC Line Conducted C 15.203 Antenna Requirements FCC 15.203 - C Note 1: C=Comply NC=Not Comply NT=Not Tested NA=Not Applicable Note 2: For radiated emission tests below 30 MHz were performed on semi-anechoic chamber which is correlated with OATS. Report No.: DRTFCC2002-0033 FCC ID: 2AU9T-CART1C TRF-RF-204(06)170613 Prohibits the copying and re-issue of this report without DT&C approval. Pages: 8 / 16 4.2 Transmitter requirements 4.2.1 20 dB Bandwidth - Procedure: The 20 dB Bandwidth is measured with a spectrum analyzer connected via a receive antenna placed near the EUT while the EUT is operating in transmission mode. A…

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FCC ID : 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. Test Setup Photo of Radiated Measurement EUT Position: X-axis FCC ID : 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. Test Setup Photo of Radiated Measurement (0.009 ~ 30MHz) FCC ID : 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. Test Setup Photo of Radiated Measurement (below 1000MHz)) FCC ID : 2AU9T-CART1C Copyright Ⓒ 2020, DT&C Co., Ltd. Test Setup Photo for AC line conducted