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 Dept. Name or Position Author Review Review Review Review R&D RA BD manager R&D manager CEO Name Sungmi Jo Kyungeun Yoo Yumi Ji Changhyun Byunghwan Baik Lee Signature Date Revision information 2019.05.24 Initial release No. Date Description Remark 2019.12.18 Corrective action of 1st MTIC review & add the FCC requirements 0 1 F401-01(A-190102) Sky Labs Inc.
(Contents) Chapter Contents Remark Device description & Intended use 1 2 3 4 5 6 7 8 9 10 11 12 14 15 Packages Device specification Environment specification Symbols Safety Precautions Contraindications Disposal Warranty Operation Installation & Charging Information on EMC FCC Compliance state 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.
#703, 58, Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Sky Labs Inc. 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. Youll 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) A0K1 A0K2 A0K3 A0K4 A0K5 A0K6 A0K7 A0K8 4. Intended use 5. General information Part CART-Ring Model number of CART-Ring Model number of CART-Cradle R0K1 R0K2 R0K3 R0K4 R0K5 R0K6 R0K7 R0K8 C0K1 C0K2 C0K3 C0K4 C0K5 C0K6 C0K7 C0K8 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. Feature Rated Power Max power(R0K1) BT frequency Internally Powered, Lithium polymer battery, 3.7 Vd.c.
-4 dBm(Burst Average power) Charging frequency : 205kHz Operating frequency : 2402-2480MHz IP58
-20 ~ 50 Continuous IP Grade Temperature Mode of operation Protection against electric shock Grade II / Internally Powered, BF type applied part, Body-worn Bluetooth Low Energy, Bluetooth 5.0, distance: <2m Ver.1.0.0 5Vd.c. 50mW~5W Wireless Charging / Operating Frequency < 205kHz /
Magnetic Inductive / using USB cable CART-Cradle RF specification Firmware Rated Power Rated Power Consumption Charging method 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 Operating & Charging Temperature Operating & Charging Humidity Storage/Transport Temperature Storage/Transport Humidity Description 5~45 10%~95%
-25 to 70 10%~95%
Operating & Storage/Transport Atmospheric Pressure 700hPa to 1060hPa CHAPTER 5. Symbols 1. Box symbols Fragile, handle with Keep dry Limitation for Transport and storage care 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 Manufacturers EU Representative information F401-01(A-190102) Sky Labs Inc. IP Grade Do not dispose with household waste Warning : Indicates a potentially hazardous situation which, if not avoided, could result in property Direct current 3. IFU Symbols damage F401-01(A-190102) Sky Labs Inc. CHAPTER 6. Safety Precautions Warning : Failure to follow these safety precaution could result in fire, electric shock, injury, or damage to CART-I or other property. Read all the safety information below before using the device. This device has been designed by Harmonized standard of medical devices IEC 60601-1, IEC 60601-1-2, Safety information IEC 60601-1-11, MDD 93/42/EEC. The patient is an intended operator(user). Limitation of use This device is intended only for adults. Users should wear the CART-Ring only on their fingers. (not on toes) General safety/cautions Do not leave your device on the place can be reached by children or pet. Do not adjust, repair, open, disassemble, or modify this device. Injury or device damage could occur. Do not use damaged cables. Do not use damaged devices. In case of operating difficulties, do not continue using the device. Do not use your device if it becomes uncomfortably warm during use. If you experience redness or skin irritation on your finger around the sensor due to your device, remove it immediately. If symptoms persist longer than 2-3 days of not using your device, please contact a dermatologist. If you dont wear a CART-Ring of inappropriate size, it cannot be guaranteed of the accuracy of the heart rate and it can cause injury or interfere with blood circulation. The battery in the CART-Ring cannot be replaced, but it is specified to have 80% of capacity left after 2 years. This device is IP58. It means, the device is protected from limited dust ingress and protected from long term immersion up to a specified pressure. This device is waterproof. But it should be kept dry. Keep your child safe from usb cable that could choke, suffocate, or strangle. Affects your heart rate reading Skin perfusion (or how much blood flows through your skin) is one factor. If youre exercising in the cold, for example, the skin perfusion in your wrist might be too low for the heart rate sensor to get a reading. Permanent or temporary changes to your skin, such as some tattoos, can also impact heart rate sensor performance. Motion is another factor that can affect the heart rate sensor. Cleaning Do not autoclave or submerge the device in any cleaning solution. This will seriously damage the device. Clean the surface of the CART-Ring with a soft cloth before you put it on your finger. Clean CART-Ring once a day before wearing on F401-01(A-190102) Sky Labs Inc. Radio frequency / Electromagnetic / Environment Do not expose to strong electromagnetic fields. Do not use the device together with MRI, CT or X-ray equipment. This device contains components and radios that emit electromagnetic fields. Do not store in extremely hot, cold, humid, wet, or bright conditions. Do not use or store this device near an open flame. Do not wear CART-Ring in the sauna or steam room. Use this device within the environment condition being described. Do not swallow CART-Ring or any small parts of the device. Do not use unauthorized power adapter and power cable. Intended use Use this device to measure heart rate and to analyze the heart rhythm to detect atrial fibrillation. Do not use this device for any other purpose than intended use being described. Do not use to diagnose heart related conditions. This device is an aid to the medical professional to monitor heart rate and atrial fibrillation. SKY Labs Inc. makes no warranty for any data or information that is collected erroneously by the device, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect, or failure to maintain the devices as instructed. Interpretations made by this device are potential findings, not a complete diagnosis of cardiac conditions. Doctors should make diagnosis in conjunction with clinical manifestation and symptoms. This device can be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum. F401-01(A-190102) Sky Labs Inc. There are no known contraindications for CART-I, although care should be taken when considering using the device CHAPTER 7. Contraindications according to the safety precautions. CHAPTER 8. Disposal CHAPTER 9. Warranty or refund up to 30 days after it ships. CART-Ring and/or battery should not be disposed of with household waste. Dispose of the device and/or battery in accordance with local environmental laws and guidelines. This device will come with 1years warranty from the date you receive it. You can also return the device for an exchange F401-01(A-190102) Sky Labs Inc. CHAPTER 10. Installation & Charging Installation (Download the application) (ONLY FOR iOS) On your compatible iPhone, download the CART-App from the App store. Please search CART in the search box. Open the CART-App and follow the onscreen instructions to use the device. Charging the CART-Ring Check the remaining charge of your CART-Ring using CART-App (mobile application). If battery is low, put CART-Ring down on CART-Cradle(charger). When charging, LED on the CART-Cradle keeps the red light on. When the battery is fully charged, LED keeps the green light on. You can use CART-Ring for 48hours continuously and you need to charge it for 2 hours. F401-01(A-190102) Sky Labs Inc. Note : Recommend using 1~2As adaptor of rated power, e.g. adaptor used for mobile phone. If not, any errors on charging can occur or more time can be needed until fully charged. Note : If LED is on the CART-ring or blinks on CART-Cradle, battery is not charging. Please put CART-
Ring down on CART-Cradle appropriately. LED Indicator When power is connected : A Green LED on the CART-Cradle will blink one time. When CART-Ring is charging : A Red LED on the CART-Cradle will flash. When charging is completed : A Green LED on the CART-Cradle will flash. Some errors occurred while charging : Red LED on the CART-Cradle will be blink continuously. F401-01(A-190102) Sky Labs Inc. CHAPTER 11. Operation(CART-App) A. Getting started 1) Download CART-App from iPhones App Store. 2) Click on CART icon and go through the Login or Sign up process. B. Login & Sign up Creating a new account 1) Click on Sign up to create a new account if you dont have an account. 2) Fill out the form. A. Click the E-mail and enter your e-mail address B. Click the Gender and choose your gender by scrolling up and down. C. Click the Name and enter your name. D. Click the Birthday and specify your birthday by scrolling up and down with the days, months, and years. E. Click the Password and set a password. Choose a strong password to protect your information and account. Then, click the Password check and retype your password. F. After completing, click the 'Join' button. Then, a verification email will be sent to the email address you entered. F401-01(A-190102) Sky Labs Inc. F401-01(A-190102) Sky Labs Inc. 3) Click the hyperlink in the email you received to complete the sign-up process. Note : If the email address you entered is already registered, a verification message will not be sent. Login to your account 1) Enter the email address and password you created previously. 2) If you want to save the ID, swipe 'save ID' to the right to activate it. 3) To activate auto login, swipe Auto Login to the right. 4) Click the Login button. F401-01(A-190102) Sky Labs Inc. Forgot Password 1) If you forgot your password, click the 'Forgot Password' button. 2) Enter the email you used to sign up and click the return button on the keyboard. A password change guide will be sent to the email address you entered. And a confirmation code will be sent to the email. F401-01(A-190102) Sky Labs Inc. 3) Check the code on the email you registered and put its code on the App. 4) Enter a new password in CART-App. 5) Try to login with the changed password in CART-App. F401-01(A-190102) Sky Labs Inc. If there is no CART-Ring registered for the ID after login completion, the Device registration page appears. C. Device Registration 1) Turn on the Bluetooth of the mobile phone. 2) Scan QR code inside the package. 3) After scanning the QR code, you can set the name of CART-ring as your own device Note : When register, please ensure CART-Ring near to your mobile phone. D. Measuring Heart rhythm Self check 1) Click the 'Measure' button on the Main page to move to Self check page 2) Press the Start button when a user is ready to check. The measurement proceeds for about 30 seconds. Note : Top cover of CART-Ring should be facing upwards. Note : Wear a CART-Ring on the finger of one hand and touch the finger of the other hand on the CART-Ring. Note : Ensure CART-Ring is fit to your finger. If not, Heart rate and AF symptoms cannot be measured with accuracy. Note : For more accurate measurement, when using check, stop doing something and hold posture for 30 seconds. F401-01(A-190102) Sky Labs Inc. 3) The progress of Self check is displayed at the top of the page. Hold your posture until progress is 100%. 4) After measuring, a result is displayed on the page. The detection of AF symptoms is displayed at the top of the page. Click on the Complete button to return to the main page. Note : The self check result can be checked again in the History tab. F401-01(A-190102) Sky Labs Inc. Tap check 1) Tapping CART-Ring twice when a user wants to check without running CART-App. 2) Take the same posture as Self check and hold for 30 seconds. Note : After tapping twice, if tap check is working, the white LED on CART-Ring will flicker twice. 3) The results can be checked in the History tab when CART-App and CART-Ring are synchronized. Note : Synchronization between CART-App and CART-Ring is done automatically. Note : If you cannot check the results in the History tab, check the Bluetooth connection. Background check 1) CART-Ring periodically measures a user's heart rhythm every 10 seconds without running CART-App. 2) The results can be checked in the History tab when CART-App and CART-Ring are synchronized. Note : The background check is measured only by the hand wearing the CART-Ring. Note : Synchronization between CART-App and CART-Ring is done automatically. Note : If you cannot check the results in the History tab, check the Bluetooth connection. F401-01(A-190102) Sky Labs Inc. E. Report - statistics data by period Press Report tab to check the statistics data by period. Monthly Report Press 'Month' buttons at the bottom of the page. The bar graph shows how many times a week was measured during the month. The count without AF symptoms is indicated in blue, and the count with AF symptoms is indicated in red. Weekly Report Press 'Week' buttons at the bottom of the page. The bar graph shows how many times a day was measured during the week. The count without AF symptoms is indicated in blue, and the count with AF symptoms is indicated in red. Daily Report Press 'Day' buttons at the bottom of the page. The bar graph shows how many times an hour was measured during the day. The count without AF symptoms is indicated in blue, and the count with AF symptoms is indicated in red. F401-01(A-190102) Sky Labs Inc. F. History - previously measured data 1) Click the History tab at the bottom of the main page to view the previously measured history. 2) Can be only reviewed relevant data as choosing Check Mode
(Self check, Tap check, background check, All) 3) Can be reviewed relevant data as choosing the AF symptom of AF or Non AF. (AF, Non AF, All) 4) Can be reviewed relevant data during the measured period as choosing the date. 5) Check detailed result as choosing a certain item from the list Note : You can check ECG and PPG graphs in self check and tap check data, and only PPG graph in background check data. G. Setting User info 1) Edit Click the User info button in Setting to manage your logged-in account. F401-01(A-190102) Sky Labs Inc. A. Click the Edit button in the upper right corner of the page. B. Tap the item you want to modify and edit the information. C. Click the 'Confirm' button on the upper right side of the page to save. 2) Login to another account A. Click on the Logout button under your name. B. Login by entering Email and Password of the account to register. F401-01(A-190102) Sky Labs Inc. Doctor info 1) Register Click the Doctor button in Setting to manage your doctor. A. Click the input box under Search Doctor and enter your doctors number. B. Click the button. C. Select the searched item. D.
'Do you want to apply? Select 'OK' to the query F401-01(A-190102) Sky Labs Inc. Device info 1) Add Click the device button in Setting to manage your devices. At the top of the page, recently connected device is displayed. In the list, a blue dot is displayed next to the connected CART-Ring number. A. Press the 'Add Device' button at the bottom. B. Scan QR code inside the package.
(CART-App connects automatically with the device you add.) Note : When register, please ensure CART-Ring near to your mobile phone. 2) Delete A. Swipe the CART-Ring number you want to delete to the left. B. Press the Delete button when it is active. 4) Connect to another device A. Press the CART-Ring number you want to connect. B. Check the blue dot next to the CART-Ring number you want to connect. F401-01(A-190102) Sky Labs Inc. Push info Press the Push info' button in Setting to set whether to receive a notification. To receive the notification, swipe the button for Push Setting to the right. Setting data usage Set the data usage limit. If you want to use only data traffic via Wi-Fi, please be active WiFi Only by Swiping. Term of service & License Term of service and open framework information for using CART-App. F401-01(A-190102) Sky Labs Inc. F401-01(A-190102) Sky Labs Inc. CHAPTER 12. Information on EMC 1. Guidance and Manufacturers Declaration Electromagnetic Emissions
- The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test Compliance Electromagnetic environment - Guidance RF Emissions CISPR 11 Group 1 The EUT uses RF energy only for its internal function. RF Emissions CISPR 11 Class A Harmonic 61000-3-2 emissions IEC A Voltage fluctuations / Flicker emissions IEC 61000-3-3 Complies Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The EUT is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 2. Guidance and Manufacturers Declaration Electromagnetic Immunity
- The EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment - Guidance Test level Electrostatic discharge
(ESD) 8kV Contact 8kV contact 2kV, 4kV, 8kV, 15kV air 15kV air fast 2kV 100kHz frequency 2kV 100kHz frequency repetition repetition Surge Line-to-line 0.5kV, 1kV 1kV Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should Mains power quality should be that of a typical hospital environment. commercial or Mains power quality should be that of a typical hospital environment. commercial or 0.5kV, 1kV, 2kV 2kV IEC 61000-4-2 Electrical transient/burst IEC61000-4-4 IEC 61000-4-5 Surge Line-to-ground IEC 61000-4-5 IEC 61000-4-11 Voltage dips 0 % UT; 0,5 cycle 0 % UT; 0,5 cycle At 0, 45, 90, 135, 180, 225, 270 and 315 At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage interruptions 0 % UT; 1 cycle 0 % UT; 1 cycle IEC 61000-4-11 and 70 % UT; 25/30 cycles and 70 % UT; 25/30 cycles Single phase: at 0 Single phase: at 0 or commercial Mains power quality should be that of a typical hospital environment. If the user of the EUT image intensifier requires continued operation during power mains interruptions, it is recommended image intensifier an uninterruptible power supply or a battery. the EUT powered from that be F401-01(A-190102) Sky Labs Inc. 30A/m 30A/m RATED power frequency magnetic fields
(50/60Hz) IEC 61000-4-8 Conducted disturbances induced by RF fields 3V IEC 61000-4-6 3V 0.15 MHz 80MHz 0.15 MHz 80MHz 6V in ISM bands between 0.15 MHz and 6V in ISM bands Between 0.15 MHz and 80MHz 80% AM at 1kHz 80MHz 80%AM at 1 kHz Radiated RF EM fields 3V/m 3V/m IEC 61000-4-3 80MHz 2,7GHz 80MHz 2,7GHz 80% AM at 1kHz 80%AM at 1kHz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Portable and mobile RF communications equipment should be used no closer to any part of the EUT, including cables, than the recommended distance calculated from the equation applicable to the frequency of the transmitter. separation Where P is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in meters(M). Field strengths from fixed RF transmitters as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol;
F401-01(A-190102) Sky Labs Inc. CHAPTER 14. FCC Compliance Statement This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions;
1) This device may not cause harmful interference. 2) This device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, used and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment on and off, the user is encouraged to try to correct the interference by one or more of the following measures;
Reorient or relocate the receiving antennae Increase the separation between the equipment and the receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. FCC RF Exposure Statement This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. The antenna used for this transmitter must not transmit simultaneously with any other antenna or transmitter except in accordance with FCC multi-transmitter product procedures. FCC Caution This equipment may generate or use radio frequency energy. Changes or modifications to this equipment may cause harmful interference unless the modifications are expressly approved in the instruction manual. This user could lose the authority to operate this equipment if an unauthorized change or modifications is made. FCC ID: 2AU9T-CART1C The antenna (or antennas) must be installed so as to maintain at all times a distance minimum of at least 20 cm between the radiation source (antenna) and any individual. FCC ID: 2AU9T-CART1R This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. F401-01(A-190102) Sky Labs Inc. CHAPTER 15. Trouble Shooting A. Self-Check Error or error message Cause Recommended solutions No Bluetooth connection. Check BLE connection. BLE connection is needed to Do self-check again synchronize between CART-Ring and CART-App when do self-
check. No Bluetooth connection. Back to main page, wait for BLE connection is needed to connecting, automatically, CART-
synchronize between CART-Ring Ring with CART-App and CART-App when do self-
Do self-check again check. Collected data is not received from Go to the Self Check Guide screen CART-Ring, appropriately automatically, retry self-check F401-01(A-190102) Sky Labs Inc. B. General (CART-App) Error or error message Cause Recommended solutions Required Permission is denied Accept Required Permission Until accepting the Terms of Select the Agree button at the Service, this service is not bottom of the screen, available. The Next button is activated. By selecting this button, you agree to the terms and proceed to the next screen. Bluetooth is disabled on the Turn on the Bluetooth in the mobile device. System setting Fail to search CART-Ring Approach CART-Ring and mobile device with CART-App within 2 meters Try to search again Problem with initializing CART-
Plug and un-plug CART-Ring to Ring CART-Cradle several times Open CART-App again Note : If you face to these kinds of trouble consistently, please contact Sky Labs Inc. at +82-31-8092-3290 and www.i-skylabs.com Local time : 09:00-18:00 (GMT+9) F401-01(A-190102) Sky Labs Inc.