SkyLabs CART-I User manual

◆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. Environment specification .........................................................................................................................................8
5. Symbols .......................................................................................................................................................................9
6. Safety Precautions ....................................................................................................................................................10
6.1. Safety information ..........................................................................................................................................10
6.2. Limitation of use .............................................................................................................................................10
6.3. General safety / warnings ..............................................................................................................................10
6.4. Precautions/warnings for reading Heart rates and ECG (how to collect signals) ...................................10
6.5. Product management .....................................................................................................................................11
6.6. Radio frequency / Electromagnetic field / Environment .............................................................................11
6.7. Maintaining water and dust resistance......................................................................................................... 11
6.8. Intended use....................................................................................................................................................12
6.9. Disposal of the device and/or battery in accordance with local environmental laws and guidelines. ..12
7. Contraindications......................................................................................................................................................13
8. Disposal .....................................................................................................................................................................13
9. Quality Assurance and Limited Warranty...............................................................................................................13
10. Installation & Charging...........................................................................................................................................13
10.1. Installation (app download) .........................................................................................................................13
10.2. How to charge CART-Ring ...........................................................................................................................13
10.3. How to place (and charge) CART-Ring on the CART-Cradle....................................................................14
10.4. LED Indicator of CART-Cradle.....................................................................................................................14
11.1. Preparation before use .................................................................................................................................15
11.1. Product installation & registration ..............................................................................................................15
11.3. How to sign up/log in....................................................................................................................................15
11.4. Forgot password ...........................................................................................................................................17
11.5. Register CART (CART-Ring) ........................................................................................................................18

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. Information on EMC ................................................................................................................................................30
12.1. Guidance and Manufacturer's Declaration (electromagnetic emissions)...............................................30
12.2. Guidance and Manufacturer's Declaration (electromagnetic Immunity) ................................................30
13. FCC Compliance Statement ...................................................................................................................................33
14. Troubleshooting and Update .................................................................................................................................34
14.1. Self-check ......................................................................................................................................................34
14.2. General (CART-App) .....................................................................................................................................34
15. Label .........................................................................................................................................................................34
15.1. Labelling Position of CART-Ring ................................................................................................................34
15.2. Labelling Position of CART-Cradle .............................................................................................................35
15.3. Labelling Position of GIFT Box ...................................................................................................................35

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.
The publication date of this instruction manual (IFU# IF-01 Rev. D) is Nov. 2020. In the case where you have a manual
that goes back 3 years, please contact Sky Labs Inc. to make sure you have all the updated information.
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.
Address:
#703, 58, Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do,
Korea
Website:
http://www.skylabs.io
E-mail:
[e-mail]
Tel.:
[phone]
EC Representative:
CE Medical
Address:
#Amerlandseweg 7, 3621ZC, Breukelen, the Netherlands
Website:
http://www.ce-mark-medical.com
E-mail:
[e-mail]
Tel.:
[phone]
Country of manufacture:
MADE IN KOREA
IF-01(D-201210)

1. Device Description & Intended Use
1) CART-I consists of devices, including CART-Ring and CART-Cradle, CART-App (Mobile Application) for
general users, and CART-Web(website) for doctors.
2) 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.
3) 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.
4) CART-Ring operates continuously to collect only PPG signals - referred to as "Background-Check" within this
submission.
5) without user intervention, while collecting both PPG and ECG signals - referred to as "Self-Check" within this
submission by users' intention.
6) Inside of CART-Ring, a Lithium Polymer battery can be recharged using CART-Cradle, operating based on the
wireless charging technique.
7) CART-I utilizes an iOS-based CART-App, which is installed on an iPhone, to obtain PPG and ECG signals from
CART-Ring.
8) 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.
9) 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.
10) 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.
11) CART-I has the accuracy of heart rate as below.
Contents
The accuracy of heart rate
Method for calculating the heart rate
PPG Heart rate
40 bpm~240 bpm (±2)
The number of pulses during the measurement period.
ECG Heart rate
30 bpm~240bpm (±3)
The average of the inverse of the individual
R-R interval during the measurement period.
2. Packages
A smartphone for installation of CART-App is not enclosed.
Minimum smartphone requirements to operate CART of Sky Labs Inc.
ㆍSmartphone: iPhone 7 or later, iOS 10.0 or later, Android 6.0 or later (BT 4.1 or higher)
ㆍYou may download CART-App from Apple App Store and Google Play.

3. Device Specifications
3.1. Intended use and/or indications for use
Contents
Description
Indications
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.
Target treatment group
Adults ( ≥ 18years)
The age of Adult is defined on the basis of FRA (European union agency for
fundamental rights).
⇒ The age of majority is the age at which a child becomes an adult and acquires
full legal capacity. It means that a person can engage in legal activities and is liable
for any contractual obligations. The age of majority is 18 years in all EC Member
States except for Scotland, where children are considered to have the full legal
capacity from the age of 16 years.)
https://fra.europa.eu/en/publication/2017/mapping-minimum-age-
requirements/age-majority
Target diagnostic disease
Atrial Fibrillation, Heart rate
3.2. Product information
Contents
Description
Product name
Heart monitor
Trade name
CART-I
CE MDD Classification
Class IIa
(according to the Rule 10 of Classification Criteria, annex IX, MDD 2007/47/EC)
Trade Name / Model Name
CART-I
Applied part
BF Type
(Inner metal, sensor and outer of CART-Ring)
Model Number
CART-I has 8 types of CART-Ring and CART-Cradle. The difference between
each model number is its dimension.
CART-Ring is available in US 6 to 13, in Korea 11 to 31.
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
3.3. General product information
Part
Feature
CART-Ring
Rated Power
Internally Powered, Lithium polymer battery,
3.7 Vd.c.
Max power(R0K1)
-2.47 dBm (Burst Average power)

BT frequency
Charging frequency: 205.305kHz
Operating frequency: 2402~2480MHz
IP Grade
IP58
RF test Temperature
-20℃~ 55℃
Mode of operation
Continuous
Protection against electric shock
Internally Powered, BF type applied part, Body-
worn
RF specification
Bluetooth Low Energy, Bluetooth 5.0, distance:
<2m
Firmware Version
CART-RF 1.2.1
CART-Cradle
Rated Power
5Vd.c.
Rated Power Consumption
50mW~1W
Charging method
Wireless Charging / Magnetic Inductive /
using USB cable
RF frequency
Charging frequency: 205.305kHz
Operating frequency: 175.3kHz
Firmware Version
CART-CF 1.0.0,
CART-App
CART-AC(IOS) 1.2.0, CART-AC(Android) 1.1.1)
Language: English
CART-Web
CART-WD 1.2.0
Language: English
Manufacturing date
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)

4. Environment specification
Contents
Description
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,
and transportation
700hPa ~ 1060hPa

5. Symbols
1) Symbols on the shipping box
Fragile, handle with
Care
Keep dry
Limitation for Transport and storage
2) Symbols on the product
Manufacturer
CE marking of conformity
Lot Number
Temperature limitation
Type BF
Humidity limitation
Date of Manufacture
Atmospheric pressure limitation
Refer to the
Instruction for use
Manufacturer’s
EU Representative information
IP Grade
Do not dispose with household waste
Direct current
Warning

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. Safety information
ㆍThis product is designed and manufactured in compliance with EN 60601-1:2013 and EN 60601-1-2:2015 the
international standards applied to medical devices.
ㆍThis product is designed to be used by patients.
6.2. Limitation of use
ㆍThis product shall be used only by adults(≥18years).
ㆍCART-Ring shall be worn only on a finger; do not wear it on other part of your body.
ㆍThis product shall not be used for a medical diagnosis without the help of medical staff.
6.3. General safety / warnings
ㆍDo not place the product near children or pets.
ㆍDo not adjust, repair, disassemble or modify the product as it may cause injury or product damage.
ㆍDo not use a damaged cable.
ㆍDo not use a damaged product.
ㆍStop using the product if you experience difficulties in manipulating or using it.
ㆍDo not use the product if heat is generated while being used.
ㆍIf the finger that contacts the CART-Ring sensor turns red or develops a skin irritation, stop wearing it
immediately. If symptoms persist without wearing CART-Ring for more than 2-3 days, please contact a
dermatologist.
ㆍIf the CART-Ring does not fit your finger, accuracy of the collected data cannot be guaranteed; please note
that a tight ring may result in an injury or poor blood circulation.
ㆍThe battery in the CART-Ring cannot be replaced, but it is specified to have 80% of capacity left after 2 years.
ㆍThis product is IP58. It means, the product 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.
ㆍKeep your child safe from USB cable that could choke, suffocate, or strangle.
ㆍIf you store this device at the minimum or maximum temperature, keep it at room temperature for at least 1
hour before use.
※ Note
ㆍIn order to select the right-sized CART-Ring for your finger, you are recommended to use the Sizing Kit
provided by the manufacturer. We recommend that you wear CART-Ring on a finger, except the thumb
and little finger, of the hand that is less-frequently used. Do not wear it with other rings.
6.4. Precautions/warnings for reading Heart rates and ECG (how to collect signals)
ㆍSkin perfusion (how much blood passes through the skin) is one of the factors affecting the quality of the data
being collected. If you exercise in a cold place, the skin perfusion of your fingers may fall too low, making it
impossible for the CART's sensor to measure.
ㆍA permanent or temporary change to the skin (e.g. tattoo) may affect the performance of the measurement

sensor.
ㆍMoving your body during measurement may affect the measurement result.
ㆍAs 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. Product management
ㆍDo not wash the product with hot water or immerse it in the cleaning solution since the product may be seriously
damaged.
ㆍWipe the inside and outside of CART-Ring with a soft cloth before wearing.
ㆍClean the surface of CART-Ring once a day before wearing.
6.6. Radio frequency / Electromagnetic field / Environment
ㆍDo not expose this product to strong electromagnetic fields
ㆍDo not use this product with MRI, CT or X-ray equipment.
ㆍThis product contains RF components that emit electromagnetic fields.
ㆍStore the product away from high or low temperature, humid or wet conditions, or direct sunlight.
ㆍDo not use or store this product near fire.
ㆍDo not wear CART-Ring in the bath and sauna.
ㆍUse this product only in the recommended environmental conditions.
ㆍAs CART-Ring is a product that contains a battery, be careful not to leave the ring inside a car for a long time.
ㆍDo not swallow CART-Ring or its components.
ㆍDo not use non-certified adapters or cables.
ㆍDue to a possibility of radio interference, this device cannot support services related to human safety.
6.7. Maintaining water and dust resistance
ㆍDo not expose the CART-Ring to water moving with force.
ㆍDo not use your CART-Ring when you dive into the water, snorkel, or try any water sports in fast-flowing water.
ㆍIf the CART-Ring or your hands are wet, dry them thoroughly before handling the CART-Ring.
ㆍIf the CART-Ring is exposed to fresh water, dry it thoroughly with a clean, soft cloth. If the CART-Ring is
exposed to other liquids, such as salt water, swimming pool water, soapy water, oil, perfume, sunscreen, hand
cleaner, or chemical products such as cosmetics, rinse it with fresh water and dry it thoroughly with a clean,
soft cloth. If you do not follow these instructions, the device’s performance and appearance may be affected.
ㆍIf the CART-Ring is dropped or receives an impact, the water- and dust-resistant features of the CART-Ring
may be damaged.
ㆍDo not disassemble your CART-Ring. The water- and dust-resistant features of the CART-Ring can be
damaged.
ㆍDo not expose your CART-Ring to a dramatic change in air temperature or water temperature.
ㆍDo not dry your CART-Ring with a heating machine like a hair drier.
ㆍThe water-resistant feature of the CART-Ring can be damaged in the sauna.
ㆍSome features may not work properly if the CART-Ring is used in water.
※ Note
ㆍCART-Ring has been tested in a controlled environment (IEC60529), and the dust/waterproof rating is

IP58. Please use the above contents with caution for normal dust/waterproof function operation. Failure to
observe the above may damage the device.
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. CART-I is intended to be used in the home-healthcare environment.
ㆍUse this product only for the intended use(s).
ㆍDo not use this product for diagnosing heart diseases.
ㆍSky Labs Inc. does not provide any warranty for misleading information caused by misuse, alteration, or neglect
of the product, or the product failure due to improper maintenance (not in compliance with the manual).
ㆍThis device can be operated in at least one Member State without infringing applicable requirements on the
use of radio spectrum
ㆍThe interpretation by this product shall not be regarded as a final diagnosis of the heart condition; it is a potential
interpretation of the condition that can be considered by the doctor making a diagnosis, along with other clinical
signs and symptoms.
6.9. Disposal of the device and/or battery in accordance with local environmental laws and
guidelines.
This symbol on the product or on its packaging indicates that this product shall not be treated as household
waste. Instead it shall be handed over to the applicable collection point for the recycling of electrical and
electronic equipment. By ensuring this product is disposed of correctly, you will help prevent potential
negative consequences for the environment and human health, which could otherwise be caused by
inappropriate waste handling of this product. The recycling of materials will help to conserve natural
resources. For more detailed information about recycling of this product, please contact your local city office,
your household waste disposal service or the shop where you purchased the product.

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.
9. Quality Assurance and Limited Warranty
The warranty period is 1 year from the date of purchase. Any product that does not work as intended can
be exchanged or refunded within 30 days from the delivery date.
Details can be found at the following homepage www.i-skylabs.com.
10. Installation & Charging
10.1. Installation (app download)
ㆍFrom Google Play Store or App Store of your mobile phone, download CART-App.
ㆍType in "CART" or "Cardio tracker" to search for the app. Register your CART as guided on the screen before
use.
10.2. How to charge CART-Ring
ㆍYou can check the battery level of your CART from the main screen of the CART app.
ㆍWhile being charged, the status LED of the cradle is lit in red; once fully charged, the LED turns green.
ㆍIt takes about 2 hours to fully charge a CART and, once fully charged, it lasts for about 48 hours.

10.3. How to place (and charge) CART-Ring on the CART-Cradle.
※ Note
ㆍUse 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.
ㆍBlinking LED of CART-Ring or CART-Cradle indicates that the battery is not being charged. Please check
if the charging direction is correct once again and start charging.
10.4. LED Indicator of CART-Cradle
ㆍWhen the power is connected: Green LED is lit for 1 second
ㆍBeing charged: Red LED is lit.
ㆍFully charged: Green LED is lit.
ㆍIn case of a charging error: Red LED is blinking every 1 second

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.
11.3. How to sign up/log in
11.3.1. Sign up
1) If you do not have an account, click Sign Up to start the sign-up process.
2) Fill out the membership registration form.
(1) Tap the Email field and enter your email address.
(2) Tap the Password field and set a password that you think can better protect your personal information.
Then, click Confirm Password field and enter the password again.
※ Note
ㆍFor security, the password should be between 10 to 20 digits including "uppercase/lowercase letters, and
numbers".
(3) Tap the First Name and Last Name fields and enter your name.
(4) Tap the Sex field and select your gender.
(5) Tap the Date of birth field and select your date of birth.
(6) Tap the Location field and select your region.
(7) Tap the Height field and specify your height (cm).
Tap on the Weight field and specify your weight (kg).
(8) After filling out all the items, click Sign Up. An email will be sent to the email address you have entered
for verification. Please check your email to complete the verification process.

3) Tap the link sent by email to complete the verification.
※ Note
ㆍIf the account has already been registered, a guide message pops up (no verification email will not be
sent).
11.3.2. Log in
1) Enter your email address and password.
2) If you want to save your email address and password, swipe Save Email to the right to activate it.
3) To use the auto login function, swipe Auto Login to the right to activate it.
4) Tap Login.

11.4. Forgot password
1) If you have forgotten your password, tap Forgot password.
2) 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.

3) Check the code number included in the password-change email, and enter it in the CART-App.
4) Enter a new password.
5) Log in with the changed password.
11.5. Register CART (CART-Ring)
1) Product registration can be done as follows:
(1) Go to the Setting tab.
(2) Tap My Device.
(3) Tap Add Device to register the product (CART-Ring).
※ Note
ㆍYou can see a detailed description in "My Device> Add CART."

11.6. Measure
11.6.1. How to wear CART-Ring
1) Wear it as guided in the pictures below; the top of CART should be rotated up (towards the back of your hand).
2) The sensors of CART-Ring should face the palm side.
11.6.2. Self-check
1) Tap Measure from the main screen of the CART app to start self-check.
2) Tap Start, and then it will start the measurement in 5 seconds. Before the measurement starts, use the fingers
of the other hand (without a CART) to gently cover/contact the metal part (bottom of CART) as shown in the
figure below and measure it for 30 seconds.
3) Check other guide information by touching the left or right button on the upper guide.
※ Note
ㆍThe top of CART should be rotated up (towards the back of your hand), and the sensors should face the
palm side as guided in "How to wear CART-Ring."
ㆍUse the fingers of the other hand (without a CART) to touch the metal part of CART-Ring to collect the
ECG signals.
ㆍA CART-Ring that fits your finger should be selected. If not, heart rates and atrial fibrillation symptoms
cannot be accurately measured. Before purchasing the product, request the manufacturer's sizing kit and
select a ring size most suitable for the finger to be worn.
ㆍFor accuracy of the measurement, do not move your fingers or change your posture during measurement.

4) 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.
5) 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%.
6) When the measurement is complete, the measured results appear on the screen.
(1) Occurrence of Atrial Fibrillation
Non-detection or detection of Atrial Fibrillation
(2) PPG graph: A graph of PPG signals collected through the PPG sensor
(3) ECG graph: A graph of ECG signals collected through the ECG electrodes
Select Filter on/off to change the level of noise reduction included in the ECG signal.
Filter off prevents distortion in the ECG waveform, and Filter on reduces noise in the ECG waveform.
(4) Heart rate information
※ Note
ㆍTap Record on the main screen to view the results of "Self-check."
11.6.4. LED Indicator of CART-Ring
1) Self-check start notification: Blue light is lit for 2 seconds
2) Self-check end notification: Blue light is lit for 1 second