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SkyLabs CART-I Instructions For Use Manual

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Summary of Contents for SkyLabs CART-I

  • Page 2: Table Of Contents

    ◆Contents 1. Device Description & Intended Use .......................... 5 2. Packages ..................................5 3. Device Specifications ..............................6 3.1. Intended use and/or indications for use......................6 3.2. Product information ............................6 3.3. General product information ........................... 6 3.4. Device Specifications ............................7 4.
  • Page 3 11.6. Measure ................................19 11.7. Report (by Period) ............................21 11.8. History (previously - measured self - check records) ................23 11.9. Setting ................................24 11.10. Android device application “Optimize battery usage” not used (iOS not applicable) ......30 11.11. How to manage/store the CART while not in use ..................30 12.
  • Page 4 Instruction for Use CART-I by Sky Labs Inc. Thank you for choosing CART-I. For your safe and correct use of CART-I, please read this manual before use. Failure to follow the instructions below could result in product damage (or failure) or injury.

  • Page 5: Device Description & Intended Use

    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.

  • Page 6: Device Specifications

    3.1. Intended use and/or indications for use Contents Description 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 Indications monitor and record their heart rhythms and heart rates on an intermittent or continuous basis.

  • Page 7: Device Specifications

    YYYY-MM Country of manufacture Republic of Korea Manufactured by Sky Labs Inc. Product use period CART-I is guaranteed to use for a minimum of 2 years. 3.4. Device Specifications Contents The accuracy of heart rate PPG Heart rate 40bpm~240bpm (±2bpm) ECG Heart rate 30bpm~240bpm (±3bpm)

  • Page 8: Environment Specification

    4. Environment specification Description Contents Temperature conditions for operation & charging 5℃~45℃ Humidity conditions for operation & charging 10%~95% Temperature conditions for storage & transportation -25℃ to 70℃ Humidity conditions for storage & transportation 10%~95% Atmospheric pressure conditions for operation, storage, 700hPa ~ 1060hPa and transportation...

  • Page 9: Symbols

    5. Symbols 1) Symbols on the shipping box Fragile, handle with Keep dry Limitation for Transport and storage Care 2) Symbols on the product Manufacturer CE marking of conformity Lot Number Temperature limitation Type BF Humidity limitation Date of Manufacture Atmospheric pressure limitation Manufacturer’s Refer to the...

  • Page 10: Safety Precautions

    6. Safety Precautions Failure to comply with the safety precautions indicated in this manual is likely to result in fire, electric shock, injury, or damage to the product. Please read and understand all the safety precautions/warnings thoroughly before using the product. 6.1.

  • Page 11: Product Management

    sensor. ㆍ Moving your body during measurement may affect the measurement result. ㆍ As CART-Ring is IP58 rated (dust- and water-proof), you may use it freely in your daily life. To ensure higher quality of the collected data, however, wipe off water on your hand or CART-Ring with a soft cloth. 6.5.

  • Page 12: Intended Use

    6.8. 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.

  • Page 13: Contraindications

    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. 8. Disposal This product and its battery shall not be disposed of together with household waste. Dispose of the product and its battery in accordance with the local environmental laws and regulations.

  • Page 14: How To Place (And Charge) Cart-Ring On The Cart-Cradle

    10.3. How to place (and charge) CART-Ring on the CART-Cradle. ※ Note ㆍ Use an adapter with a rated voltage of 1 to 2 A (i.e. mobile phone adapter). Otherwise, an error may occur while charging, or it may take more time until it is fully charged. ㆍ...

  • Page 15: Preparation Before Use

    11. Operation 11.1. Preparation before use For your safe and correct use of CART-I, please read this manual before use. 11.1. Product installation & registration Download CART-App from App Store or Google Play. Tap the icon of the installed CART-App and try to log in or sign up.
  • Page 16 Tap the link sent by email to complete the verification. ※ Note ㆍ If the account has already been registered, a guide message pops up (no verification email will not be sent). 11.3.2. Log in Enter your email address and password. If you want to save your email address and password, swipe Save Email to the right to activate it.

  • Page 17: Forgot Password

    11.4. Forgot password If you have forgotten your password, tap Forgot password. Enter the email address you used to sign up and tap Send. A password-change email is sent to your email from which you may find a code number for changing your password.

  • Page 18: Register Cart (Cart-Ring)

    Check the code number included in the password-change email, and enter it in the CART-App. Enter a new password. Log in with the changed password. 11.5. Register CART (CART-Ring) Product registration can be done as follows: (1) Go to the Setting tab. (2) Tap My Device.

  • Page 19: Measure

    11.6. Measure 11.6.1. How to wear CART-Ring Wear it as guided in the pictures below; the top of CART should be rotated up (towards the back of your hand). The sensors of CART-Ring should face the palm side. 11.6.2. Self-check Tap Measure from the main screen of the CART app to start self-check.
  • Page 20 When the self-check starts, the blue LED on the top of CART lights up for 2 seconds. After 30 seconds, the blue LED lights up for 1 second, indicating that the measurement is complete. While the measurement is in progress, the progress bar is displayed at the top of the screen. Do not move until the progress bar reaches 100%.

  • Page 21: Report (By Period)

    Fault notification: Red light blinks every 1 second 11.6.5. Symptom Input/ Symptom View Symptoms can be entered at any time and the entered symptoms can be viewed. Enter the symptom by moving the "Symptom input / view" button of the application to the symptom input screen. After selecting the symptom that appears on the symptom input screen, press the “Save”...
  • Page 22 11.7.1. Monthly report Tap Monthly at the top of the Report screen. The upper figure shows Atrial Fibrillation burden (%) of the measured information corresponding to the selected month. The graph shows Atrial Fibrillation burden (%) and average heart rate based on the measured data over a month.

  • Page 23: History (Previously - Measured Self - Check Records)

    11.7.3. Daily report Tap Daily at the top of the Report screen. The upper figure shows Atrial Fibrillation burden (%) of the measured information corresponding to the selected day. The graph shows Atrial Fibrillation burden (%) and average heart rate based on the measured data over a day. 11.8.

  • Page 24: Setting

    Select the data you want to see; a more detailed information is displayed. ※ Note ㆍ You may check the PPG and ECG graphs and heart rates through self-check. 11.9. Setting 11.9.1. User information You can edit your User information by tapping Setting > User information. (1) Edit User information ㆍ...
  • Page 25 11.9.2. My physician Tap Setting > My physician to manage your registered physician(s). (1) Update the list of my physicians. ① icon at the top right of the screen. (2) Check the approval status of your physicians. ① to see the physician list guide. : Physician’s approval is completed.
  • Page 26 11.9.3. My Device To register your CART, tap Setting > My Device. At the top of the page, you will see a list of recently - connected devices (newest first); all the previously registered devices are included in the list. A blue dot on the left of the CART icon indicates it is the currently - connected device.
  • Page 27 11.9.4. Data usage limit Tap Setting > Data usage limit to limit the data usage. If you want to use only Wi-Fi, enable the toggle switch of "Use Wi-Fi Only" by swiping it to the right. 11.9.5. CART information (information of the CART app and its terms of use.) Tap Setting >...
  • Page 28 11.9.6 Notification Setting Tap Setting > Notification Setting to manage notification Settings. Allow Notifications Allow general notifications, such as battery status. If this feature is turned off, notification service will not be provided. Allow atrial fibrillation notifications Allow notification when Atrial Fibrillation occurs. If this feature is turned off, notification service will not be provided.
  • Page 29 11.9.7 Device (Ring) Update Tap Setting > Device (Ring) Update to manage notification Settings. Check the latest firmware of CART-Ring and use the firmware update function if an update is needed. (1) Charge your cart ring. If it is not in the charging status, the cart ring is not updated. (2) Place your CART-Ring and smartphone close together.

  • Page 30: Android Device Application "Optimize Battery Usage" Not Used (Ios Not Applicable)

    11.10. Android device application “Optimize battery usage” not used (iOS not applicable) If the “Optimize battery usage” function of CART App is turned on, some functions of CART may be restricted or may not operate normally. (1) If "Optimize battery usage" is in use, the setting popup will appear when the application is launched. (2) Please disable battery optimization through the pop-up.
  • Page 31 Electromagnetic environment Susceptibility test IEC 60601 Criteria Compatibility Criteria (guidelines) Floors should be wood, concrete or ±8kV Contact Electrostatic discharge ±8kV contact ceramic tile. If floors are covered ±2 kV, ± 4kV, ± 8kV, (ESD) ±15kV air with synthetic material, the relative ±15kV air IEC 61000-4-2 humidity should...
  • Page 32 Electromagnetic environment Susceptibility test IEC 60601 Criteria Compatibility Criteria (guidelines) Where P is the maximum output power rating of the transmitter in watts(W) according transmitter manufacturer and d is recommended separation distance in meters(M). Field strengths from fixed RF transmitters as determined by an electromagnetic site survey, should 3V/m 3V/m...

  • Page 33: Fcc Compliance Statement

    13. 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.

  • Page 34: Troubleshooting And Update

    Note ㆍ If your problem persists, please contact Sky Labs Inc. ㆍ Tel: +82-1599-3402 ㆍ Customer Service Hours: 09:00~18:00 (Lunch time 12:00~13:00), GTM + 9 ㆍ Website: www.i-skylabs.com. 15. Label 15.1. Labelling Position of CART-Ring Wrap the ring with ①...

  • Page 35: Labelling Position Of Cart-Cradle

    15.2. Labelling Position of CART-Cradle Attach the label inside the red circle at the bottom of the CART-Cradle. 15.3. Labelling Position of GIFT Box Attach the label inside the red square on the Gift box. (under the Bottom of the gift box)

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