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 0 2019.05.24 Initial release 1 2019.12.18 Corrective action of 1st MTIC review & add the FCC requirements F401-01(A-190102) Description Remark Sky Labs Inc.
◆ 목 차(Contents) Chapter Contents 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) Remark 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.
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.
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 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 4.
CHAPTER 4. Environment specification Item Description Operating & Charging Temperature 5℃~45℃ Operating & Charging Humidity 10%~95% Storage/Transport Temperature -25℃ to 70℃ Storage/Transport Humidity 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.
IP Grade Do not dispose with household waste Direct current 3. IFU Symbols Warning : Indicates a potentially hazardous situation which, if not avoided, could result in property 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. ■ Safety information This device has been designed by Harmonized standard of medical devices “IEC 60601-1, IEC 60601-1-2, 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.
■ 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.
CHAPTER 7. Contraindications There are no known contraindications for CART-I, although care should be taken when considering using the device according to the safety precautions. CHAPTER 8. Disposal 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. CHAPTER 9. Warranty This device will come with 1years warranty from the date you receive it.
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.
Note : Recommend using 1~2A’s 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 CARTRing 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.
CHAPTER 11. Operation(CART-App) A. Getting started 1) Download CART-App from iPhone’s 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 don’t 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.
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.
C. Device Registration If there is no CART-Ring registered for the ID after login completion, the Device registration page appears. 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.
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.
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.
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.
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 Click the ‘Doctor’ button in ‘Setting’ to manage your doctor. 1) Register A. Click the input box under ‘Search Doctor’ and enter your doctor’s number. B. Click the C. Select the searched item. D. 'Do you want to apply? Select 'OK' to the query F401-01(A-190102) button. Sky Labs Inc.
Device info 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. 1) Add 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.
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 Manufacturer’s 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.
RATED power frequency magnetic fields (50/60Hz) 30A/m 30A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 3V 3V 0.15 MHz – 80MHz 0.15 MHz – 80MHz 6V in ISM bands between 0.
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.
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 selfcheck. 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.
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, bottom of the screen, this service is not 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.
