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SkyLabs CART-I A0K2 Instructions For Use Manual

Heart monitor
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Summary of Contents for SkyLabs CART-I A0K2

  • Page 2: Table Of Contents

    ◆ Contents 1. Description and Intended Use of the Device ......................5 1.1. Intended use ..............................5 1.2. Product’s accuracy and calculation methods ....................5 2. Components ................................5 3. Product Specifications ............................... 6 3.1. Product information ............................6 3.2. Product Specifications ............................. 7 4.
  • Page 3 11.4. Changing password ............................20 11.5. Main screen ..............................23 11.6. Self-check ..............................25 11.7. My Symptoms ..............................29 11.8. Background-check ............................33 11.9. Records ................................39 11.10. My page ................................ 43 11.11. Today's Report ............................. 54 11.12. Storage and Maintenance after Use ......................55 12.
  • Page 4 If you have any questions regarding the use of the product or mobile app, please free to contact Sky Labs Inc. Manufacture: Sky Labs Inc. #702, #703, 58, Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi- Address: do, Korea Website: http://www.skylabs.io E-mail: info@skylabs.io Tel.: +82-1599-3402 EC Representative: CE Medical...

  • Page 5: Description And Intended Use Of The Device

    1. Description and Intended Use of the Device 1.1. Intended 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 6: Product Specifications

    3. Product Specifications 3.1. Product information Contents Description Product name Heart monitor Trade name CART-I Class IIa CE MDD Classification (According to the Rule 10 of Classification Criteria, annex IX, MDD 2007/47/EC) Trade Name / Model Name CART-I BF Type Applied part (Inner metal, sensor and outer of CART-Ring) CART-I has 8 types of CART-Ring and CART-Cradle.

  • Page 7: Product Specifications

    3.2. Product Specifications Category Details Internal power supply, lithium-polymer battery, 3.7 Rated power Vd.c. (RX) Non-contact charging frequency: 205 kHz Radio frequency (RF) Frequency during operation: 2402-2480 MHz Ingress protection (IP) rating IP58 RF test temperature -20℃ to 50℃ Operation mode Continuous mode CART-Ring Protection against electric shock...

  • Page 8: Environmental Requirements

    4. Environmental Requirements Category Details Operating and charging temperature 5℃ to 45℃ Operating and charging humidity 10%-95% Storage and transport temperature -25℃ to 70℃ Storage and transport humidity 10%-95% Operating, storage and transport atmospheric pressure 700 to 1060 hPa...

  • Page 9: Label Symbols

    5. Label Symbols 5.1. Symbols on the transport box Guard against Storage and transport temperature, humidity and atmospheric Handle with Care Damp pressure 5.2. Symbols on the product Date of Type BF Manufacturer manufacture Applied part European See the Conformity user manual rating (CE MDD)

  • Page 10: Safety Warnings

    6. Safety Warnings Warning: Failure to follow safety warnings specified in the user manual may result in fire, electric shock, injury or product damage. Make sure to check all safety precautions and warnings before using the product. 6.1. Safety-related information ...

  • Page 11: Precautions/Warnings Regarding Heart Rate And Ecg Interpretation (Signal Collection Method)

     If this product has been stored at a minimum or maximum temperature, keep it at a room temperature for at least one hour before use.  If you use procedures or control actions for a maneuver or maintenance that is not specified herein, this may cause exposure to hazardous radiation.

  • Page 12: Cyber Security

     If the CART-Ring or your hand is wet, thoroughly dry it before using the Ring.  If the CART-Ring is wet in clean water, use a clean, soft cloth to wipe the moisture away.  If the CART-Ring has been exposed to liquid that is not clean water (e.g., salted water, swimming pool water, soapy water, oil, or chemicals such as perfume, sunblock, hand sanitizer or cosmetics), rinse it with clean water and then use a clean, soft cloth to wipe and thoroughly dry it before use.

  • Page 13: Limitations On The Use Of The Product

    7. Limitations on the Use of the Product This product has no limitation on the collection of ECG or PPG data or the measurement of heart rate. 8. Discarding the Product This device and its battery cannot be discarded together with household waste. Discard the device and battery according to your local applicable environmental laws and regulations.

  • Page 14: Installing And Charging

    10. Installing and Charging 10.1. Installing (downloading the application)  Use your mobile device to download the CART-App from the App Store or Google Play.  Use “CART, Cardio tracker” as the search term. Follow the on-screen instructions to register the product before use.

  • Page 15: Cart-Ring Combined With The Cart-Cradle

    10.3. CART-Ring combined with the CART-Cradle Note:  Use an adapter with a rated voltage of 1 to 2 A. (It is best to use a mobile device charging adapter.) Otherwise, an error may occur while charging or it may take longer to fully charge the device. ...

  • Page 16: Using The Device

    11. Using the Device 11.1. Before Getting Started Make sure to read this user manual carefully before using the product, to ensure correct and safe use. 11.2. Initial installation and product registration Use your mobile device to download the application “CART-App” from the App Store or Google Play. Tap the installed CART-App icon and log in or sign up.
  • Page 17 11.3.2. Filling in the sign-up form Name Details Tap the “ID” field and enter your email address. Tap the “Password” field and set a password. Password Set a strong password, to protect your personal information. Tap the “Confirm Password” field and enter Confirm Password the set password again.
  • Page 18 11.3.3. Email Confirmation Name Details If a verification email has not been received, tap “Resend Email Verification” to Resend Email Verification resend a verification email. Tap “Login” to log into the application. Login Note:  If your account is already registered, a notification message appears and a user verification email is not sent.
  • Page 19 11.3.4. Login Name Details Tap the “ID” field and enter your email address. Tap the “Password” field and enter your password. Password Error message An error message appears if you enter an incorrect ID or password. To use the Auto Login feature, toggle the button that says “Remember Me” to the Remember Me right to enable the feature.

  • Page 20: Changing Password

    11.4. Changing password 1) If you forgot your password, tap “Forgot Password”. Name Details Tap “Forgot Password” to navigate to the “Reset Password” screen. Forgot Password...
  • Page 21 2) Enter the email address you used when signing up and tap “OK.” An email for changing your password is sent to the specified email address. From the received email, use the provided code to change your password. Name Details Tap the “ID”...
  • Page 22 3) Reset password Name Details Tap the “8 digits code” field and enter the “Password Verification Code” received Password Verification Code by email. A password change code is 8 digits long. Tap the "New Password" field and enter a new password. Set a strong password, New Password to protect your personal information.

  • Page 23: Main Screen

    11.5. Main screen...
  • Page 24 Name Details Data status Shows the status of data collection or transmission. Notice Displays the list of notice. Displays the “My page” screen. My page Battery level Shows the current battery level. Displays the “AF Self-check” screen. Self-Check Displays the “My Symptoms” screen. My Symptoms Displays the “Statistics”...

  • Page 25: Self-Check

    11.6. Self-check 11.6.1. Wearing the CART-Ring Name Details Wear the CART-Ring with the top placed on the back of the finger. Sensor Wear the CART-Ring with the sensor placed on the belly of the finger. 11.6.2. Self-check LED indicator Name Details Measurement start When a measurement begins, the LED indicator lights up green for 2 seconds.
  • Page 26 11.6.3. Self-Check Name Details Displays the “AF Self-check” screen. Self-Check...
  • Page 27 11.6.3.1. Measuring an Atrial Fibrillation Name Details Step 1 Follow steps 1 to 4 to perform a self-check for an Atrial Fibrillation. If you do not follow the Step 2 instructions each step, accurate measurement may not be possible. Make sure to maintain the right posture while the Step 3 measurement is in progress.
  • Page 28 Name Details Shows the progress rate while an Atrial Fibrillation self-check is in progress. Maintain the measurement posture until the progress rate reaches 100%. Self-check % When an Atrial Fibrillation measurement begins, the green LED on the Ring lights up for 2 seconds. When the measurement is complete, the green LED lights up for 1 second.

  • Page 29: My Symptoms

    11.7. My Symptoms Name Details Displays the “Symptom management” screen. My Symptoms...
  • Page 30 11.7.1. Checking my symptoms Name Details Symptom category Select and view information under a specific category. Date Select a date to view the symptoms that were entered on that date. Symptoms View saved symptoms. Tap “Enter Symptoms” to display the “Enter Symptoms” screen. Enter Symptoms To delete saved symptom information, tap “Delete”...
  • Page 31 11.7.2. Entering symptoms Name Details Tap “Enter Symptoms” to display the “Enter Symptoms” screen. Enter Symptoms From the “Enter Symptoms” screen, select the symptom(s) currently experienced Select symptom by the user. Specific symptom(s) of “Palpitation” can be selected from among the following: Specific symptoms - Pounding, Skipping, Sensations of a racing, Flip-Flopping.
  • Page 32 11.7.3. Deleting symptoms Name Details To delete saved symptom information, tap “Delete” to proceed symptom deletion. Delete Symptoms Select the symptom(s) to delete from the saved symptoms. If you do not want to delete, tap “Cancel” to cancel symptom deletion. Cancel To delete, tap “OK”...

  • Page 33: Background-Check

    11.8. Background-check Name Details The ring-type wearable device continuously collects PPG signals from the user. The main screen shows background-check data and upload status data saved on Data the ring-type wearable device. status The ring-type wearable device can save a maximum of 1,500 10-second data pieces. Data produced after the maximum is reached may be lost.
  • Page 34 11.8.1. Statistics Name Details Displays the “Statistics” screen. Statistics Displays the “AF Statistics” screen. Atrial Fibrillation Displays the “Pulse Rate Statistics” screen. Pulse Rate Displays the “Wearing Time Statistics” screen. Wearing Time...
  • Page 35 11.8.2. Viewing Atrial Fibrillation statistics Name Details View the “Daily,” “Weekly” or “Monthly” statistics of Atrial Fibrillation background- Period category check. Date Select the date to view data. View the “Daily,” “Weekly” or “Monthly” data on Atrial Fibrillation background- Statistical graph check, in a graph.
  • Page 36 11.8.3. Configuring the Atrial Fibrillation notification settings Name Details Displays the “AF Push Notification” screen. Noti Setting AF Push Turn on/off the “AF Push Notification” during background-check. Notification Set the “Notification Standard” for an Atrial Fibrillation during background-check, Notification Standard in 10-minute increments.
  • Page 37 11.8.4. Viewing pulse rate statistics Name Details View the “Daily,” “Weekly” or “Monthly” statistics of pulse rate background-check. Period category Date Select the date to view data. View the “Daily,” “Weekly” or “Monthly” data on pulse rate background-check, in Statistical graph a graph.
  • Page 38 11.8.5. Viewing wearing time statistics Name Details View the “Weekly” or “Monthly” statistics of how long the device was worn for Period category background-check. Date Select the date to view data. View the “Weekly” or “Monthly” data on the device wearing time for background- Statistical graph check, in a graph.

  • Page 39: Records

    11.9. Records 11.9.1. Records Name Details Displays the “AF Records” screen, which shows self-check records. Records...
  • Page 40 11.9.2. Atrial Fibrillation self-check records Name Details View “Monthly” or “Yearly” Atrial Fibrillation self-check records. Period category Date Select the date to view data. Shows a detailed description of the “AF Records” page. Legend Select and view “Monthly” or “Yearly” all Atrial Fibrillation self-check records or Select records Atrial Fibrillation detection records.
  • Page 41 11.9.2.3. Atrial Fibrillation detection records Name Details From the “AF Records” screen, tap a measurement record to view the Atrial Fibrillation Detection Records detection records for the PPG and ECG signals. Comprehensive Shows the results of the comprehensive analysis of the PPG and ECG in the selected analysis results Atrial Fibrillation self-check record.
  • Page 42 11.9.2.4. Viewing and downloading Atrial Fibrillation details as a PDF file Name Details Tap “View details” to preview the detection record data that can be downloaded as a View details PDF file. Tap “PDF Download” to display the screen from which you can download detection PDF Download records as a PDF file and view the data save destination folder.

  • Page 43: My Page

    11.10. My page Name Details Tap the “My page” icon to view your user information. My page Your user information saved is displayed. If you tap on the details under “My page,” you are redirected to the “My page” screen. My Physician View information on your registered physician.
  • Page 44 11.10.1. Editing user information Name Details Tap on the details under “My page” to display the “My Account Setting” screen. My page The “My Account Setting” screen shows your user information that is saved. My Account Setting Tap “Change Password” to display the “Change Password” screen. Change Password Tap “Edit”...
  • Page 45 11.10.2. My Physician 1) Viewing or registering your physician Name Details Under “My page,” tap “My Physician” to display the “My Physician” screen. My Physician Registered View information on the registered physicians. physicians Fill in the “Enter the physician code” field and perform a search. The “Physician Physician code Info”...
  • Page 46 2) Deleting your physician Name Details Under “My page,” tap “My Physician” to display the “My Physician” screen. My Physician Physician selection Select the physician to delete. Registered physician From the list of registered physicians, tap a physician to view information on the info physician.
  • Page 47 11.10.3. My CART-Ring Name Details Under “My page,” tap “My CART-Ring” to display the “CART-Ring Setting” My CART-Ring screen. Under “My page,” tap “CATR-Ring Using Guide” to display the “CART-Ring Using CART-Ring Using Guide” screen. Guide Under “My page,” tap “CART-Ring Setting” to display the “CART-Ring Setting” CART-Ring Setting screen.
  • Page 48 1) Registering device...
  • Page 49 Name Details Tap “Registration” to display the “Registration” screen. Registration Before registering a device, read the details of the “CART-Ring Registration CART-Ring Registration Guide Guide”. Tap “OK” to proceed to device registration. QR code Use the QR code that came with the product to register your device. Serial Number Use the product serial number to register your device.
  • Page 50 2) Re-register Device Name Details Tap “Re-registration” to display the “Re-registration” screen. Re-register device View the previously registered devices. Tap “Register” to display the calibration Re-registration screen screen. About Shows a description of the “Re-registration” feature. re-registration Calibration guide Before calibrating your device, view the details on how to calibrate a device. Tap “Start”...
  • Page 51 3) Remove CART-Ring Name Details Tap “…” to display the screen from which you can remove, update, or calibrate a Specific device management device. Remove CART- Tap “Remove CART-Ring” to display the “Remove CART-Ring” screen. Ring Tap “Cancel” to display the “CART-Ring Setting” screen. Cancel Tap “OK”...
  • Page 52 4) CART-Ring Update Name Details Tap “…” to display the screen from which you can remove, update, or calibrate a Specific device management device. Tap “CART-Ring Update” to display the “Update” screen. CART-Ring Update CART-Ring Update View the device update guide. Guide Tap “Start”...
  • Page 53 5) CART-Ring Calibration Name Details Tap “…” to display the screen from which you can remove, update, or calibrate a Specific device management device. Tap “Calibration” to display the “Calibration” screen. Calibration Calibration guide View the device calibration guide. Tap “Start” to proceed to a device calibration. Start After the device calibration is complete, tap “Main”...

  • Page 54: Today's Report

    11.11. Today's Report Name Details Shows the Atrial Fibrillation self-check records for today and displays the “AF AF Self-check Records” screen. Shows the Atrial Fibrillation burden obtained from the background-check today AF Statistics and displays the “AF Statistics” screen. Pulse Rate Shows the range of the pulse rate background-check for today and displays the “Pulse Rate Statistics”...

  • Page 55: Storage And Maintenance After Use

    11.12. Storage and Maintenance after Use If the product will not be used for an extended period of time, separate the CART-Ring, CART-Cradle and USB cable from one another for storage.

  • Page 56: Electromagnetic Compatibility

    12. Electromagnetic Compatibility 12.1. Guidelines and manufacturer's declaration – Electromagnetic emission This product is intended to be used in specified electromagnetic conditions, as detailed below. The user must use this product in an environment that meets the following conditions. Electromagnetic environment – Guidelines Emission testing Compatibility This product uses RF energy for its internal features...
  • Page 57 where P is the transmitter’s maximum power rating (W), which depends on the transmitter manufacturer, and d is the recommended separation distance (M). The fixed RF transmitter’s field strength, decided from a survey by the relevant electromagnetic compatibility website, must be smaller than the compatibility level for each frequency range.

  • Page 58: Troubleshooting And Update

    Charge the CART-Ring. battery level is low. Note:  If any of the problems above occurs persistently, please contact Sky Labs Inc. for assistance.  Main phone number: 1599-3402  Customer Service Center service hours: 09:00-18:00 (lunch break: 12:00-13:00)  Website: www.skylabs.io...

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