SkyLabs CART-I A0K2 User manual

◆ 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. Environmental Requirements ....................................................................................................................................8
5. Label Symbols .............................................................................................................................................................9
5.1. Symbols on the transport box .........................................................................................................................9
5.2. Symbols on the product...................................................................................................................................9
6. Safety Warnings ........................................................................................................................................................10
6.1. Safety-related information .............................................................................................................................10
6.2. Limitations on the use....................................................................................................................................10
6.3. General safety precautions/warnings...........................................................................................................10
6.4. Precautions/warnings regarding heart rate and ECG interpretation (signal collection method) ...........11
6.8. Product maintenance .....................................................................................................................................11
6.9. Radio frequency / electromagnetism / environmental requirements ........................................................11
6.10. Ingress protection.........................................................................................................................................11
6.11. Cyber security ...............................................................................................................................................12
7. Limitations on the Use of the Product ....................................................................................................................13
8. Discarding the Product.............................................................................................................................................13
9. Warranty and Limited Warranty ...............................................................................................................................13
10. Installing and Charging ..........................................................................................................................................14
10.1. Installing (downloading the application) ....................................................................................................14
10.2. Charging the CART-Ring..............................................................................................................................14
10.3. CART-Ring combined with the CART-Cradle.............................................................................................15
10.4. LED indicator on the CART-Cradle .............................................................................................................15
11. Using the Device .....................................................................................................................................................16
11.1. Before Getting Started..................................................................................................................................16
11.2. Initial installation and product registration ................................................................................................16
11.3. Sign-up and Login.........................................................................................................................................16

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. Electromagnetic Compatibility ..............................................................................................................................56
12.1. Guidelines and manufacturer's declaration – Electromagnetic emission..............................................56
12.2. Guidelines and manufacturer's declaration – Electromagnetic susceptibility ......................................56
13. Troubleshooting and Update .................................................................................................................................58
13.1 Self-check .......................................................................................................................................................58
13.2 General (CART-App) ......................................................................................................................................58

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. G) is 10. May. 2022. 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:
#702, #703, 58, Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-
do, Korea
Website:
http://www.skylabs.io
E-mail:
[email protected]
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(B-220406)

1. Description and Intended Use of the Device
1.1. Intended 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
1.2. Product’s accuracy and calculation methods
Item
Category
Measurement range/accuracy
ECG
Data-based heart rate collected via PPG
40-240 bpm(±2bpm)
Data-based heart rate collected via ECG
30-240 bpm(±3bpm)
2. Components
A smartphone, to which to install the CART-App, is not included in the package.
To use a product made by Sky Labs Inc., several items are required in addition to the package contents.
Smartphone: ≥iPhone 7, ≥iOS 10.0, ≥Android 6.0 (and ≥BT 4.1)
The CART-App can be installed from the Apple App Store or Google Play.

3. Product Specifications
3.1. 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

3.2. Product Specifications
Category
Details
CART-Ring
Rated power
Internal power supply, lithium-polymer battery, 3.7
Vd.c.
Radio frequency (RF)
(RX) Non-contact charging frequency: 205 kHz
Frequency during operation: 2402-2480 MHz
Ingress protection (IP) rating
IP58
RF test temperature
-20℃to 50℃
Operation mode
Continuous mode
Protection against electric shock
Internally powered equipment, BF applied part
RF spec.
Bluetooth Low Energy (BLE), BT 5.0, distance: <2m
PPG LED
Specification
Red
660nm (IF=10mA), Optical power: Max 0.35mW
IR
940nm (IF=10 mA), Optical power: Max 0.35mW
Green
525nm (IF=10 mA), Optical power: Max 1.00mW
CART-Cradle
Rated power
5 Vd.c.
Power consumption
50 mW to 1 W
Charging method
(TX) wireless charging / magnetic induction type /
using a USB cable
Radio frequency (RF)
(TX) non-contact charging frequency: 205 kHz
(TX) operating frequency: 175.3 kHz
CART-App
Language: English
Version: Shown in My Info on the mobile application main screen
Year/month of
manufacture
YYYY-MM
Country of
manufacture
Republic of Korea
Manufacturer
Sky Labs Inc.
Product's service
life
We guarantee that the internal battery of the CART-Ring can be used for at least 2 years
under conditions of normal use.

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

5. Label Symbols
5.1. Symbols on the transport box
Handle with Care
Guard against
Damp
Storage and transport temperature, humidity and atmospheric
pressure
5.2. Symbols on the product
Manufacturer
Date of
manufacture
Lot
Type BF
Applied part
See the
user manual
IP
rating
DC
European
Conformity
(CE MDD)
Temperature
limits
Humidity
limits
Atmospheric
pressure
limits
EC
Representat
ive
Do not dispose
as household
waste
Caution

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
This product is designed and made to meet “IEC 60601-1, IEC 60601-1-2” which is international standards
applicable to medical equipment.
When using this product, make sure to follow the Medical Service Act, GDPR and other applicable laws and
regulations.
6.2. Limitations on the use
This product shall be used only by adults(≥18years).
The CART-Ring can be put on a finger only. Ensure that it is not put on a body part that is not a finger.
This product cannot be used to diagnose any disease without assistance by a medical professional.
Do not use this product for purposes other than the specified intended use.
Do not use this product for diagnosis of a cardiac disorder.
Sky Labs Inc. does not guarantee any data resulting from malfunction of the device caused by abuse, misuse,
modification or negligence of the product, an accident, or failure to perform maintenance as instructed in the
user manual.
Interpretation using this product is not a complete diagnosis of heart conditions but a latent result. Physicians
should diagnose by viewing clinical features and manifestation.
If this product produces a result indicating the possibility of an Atrial Fibrillation, consult a medical specialist for
accurate diagnosis.
The product may display a waveform that indicates the possibility of an Atrial Fibrillation or atrial fibrillation
when the patient has another underlying disease.
6.3. General safety precautions/warnings
Do not leave this product in a location where there are children or pets.
Do not modify, repair, dismantle or alter this product. Injury or product damage may occur.
Do not use a damaged cable.
Do not use the product if it is damaged.
If you experience difficulty in using the product, stop using it.
If the product temperature increases during use, stop using it.
If the finger area around the CART-Ring sensor turns red or skin irritation is experienced in that area,
immediately remove the Ring. If the symptom persists for more than a couple of days after removing the Ring,
consult a dermatologist.
If you do not choose a CART-Ring that fits your finger size, the accuracy of collected data cannot be guaranteed,
which may result in injury or a blood-flow disorder.
It is not recommended that a patient with a pacemaker uses this product, because the accuracy of ECG records
cannot be guaranteed.
The battery embedded in the CART-Ring is not replaceable. The guaranteed battery life is 2 years. After 2
years of use, the battery performance becomes approximately 80%.
It takes about 2 hours to fully charge the CART-Ring. A fully charged Ring can be used continuously for about
48 hours.
Handle the USB cable with care, because it can choke or strangle a child.

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.
Note:
To choose an appropriate CART-Ring size for your finger, it is recommended to use the sizing kit provided
by the manufacturer. It is best to put on the Ring on a finger on the less frequently used hand, that is not the
thumb or little finger. Do not wear the Ring together with other finger rings.
6.4. Precautions/warnings regarding heart rate and ECG interpretation (signal collection
method)
Skin perfusion (how much blood passes through the skin) is one of the factors that affect the quality of collected
data. If you exercise in a cold place, your finger skin perfusion is so low that the read-out capability of the
sensor in the product may decrease.
A permanent or temporary change to your skin, such as a tattoo, may affect the sensor performance.
Moving your body during measurement may affect the measurement result.
The CART-Ring has an ingress protection rating of IP58, which is daily life waterproof. Nevertheless, if your
hand or the CART-Ring is wet, use a soft cloth to wipe the moisture away, to increase the quality of collected
data.
6.5. Product maintenance
Do not clean this product with hot water or immerse it in a cleansing solution. The product may become
seriously damaged.
Before wearing the CART-Ring, use a soft cloth to wipe the inner and outer surfaces.
Once a day, wipe the surfaces of the CART-Ring before putting it on.
6.6. Radio frequency / electromagnetism / environmental requirements
Do not expose this product to a strong electromagnetic field.
Do not use this product together with MRI, CT or X-ray equipment.
This product contains electromagnetic field-emitting components and uses radio frequencies.
Do not store the product in a location that is exposed to extremely high or low temperature, humidity, moisture,
or direct sunlight.
Do not use or store this product in a location with naked flames.
Do not wear the CART-Ring in a bathhouse or sauna.
Use this product under the specified environmental conditions only.
The CART-Ring comes with an embedded battery. Do not leave it inside an automobile for a prolonged period
of time.
Do not put the CART-Ring or other component in your mouth or swallow it.
Do not use an uncertified adapter or cable.
This radio equipment cannot be used for any life safety-related service, because there is a risk of radio
interference.
6.7. Ingress protection
Be careful and ensure that the CART-Ring does not come into contact with high-pressure water.
Do not wear the CART-Ring when playing a water sport in fast-flowing water, diving or snorkeling.

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. If you use it without drying it, the
performance or the exterior may become affected.
Be careful and ensure that the CART-Ring is not dropped or impacted. The waterproof or dustproof
performance may be affected.
The CART-Ring cannot be dismantled. Do not dismantle it. The water/dust-proof (ingress protection)
performance may be affected.
Do not expose the CART-Ring to extreme air or water temperature fluctuations.
Do not dry the CART-Ring using a heat generating device, such as a hair dryer.
Do not wear the CART-Ring in a sauna or steam bath. The waterproof performance may be affected.
Note:
The CART-Ring was tested under controlled environmental conditions (IEC60529) and has an ingress
protection rating of IP58. For the ingress protection to work properly, follow the instructions specified above.
Failure to follow the instructions above may damage the product.
6.8. Cyber security
If a problem relating to cyber security for this product occurs, report it to the manufacturer and wait for the
administrator to fix the problem.

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.
9. Warranty and Limited Warranty
The warranty of this product is valid for one (1) year from the date of purchase. A defective product can be replaced or
refunded within a maximum of 30 days after the date of delivery.

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.
10.2. Charging the CART-Ring
No.
Name
Details
1
Battery level
View the current battery level of the CART-Ring.
2
USB C Type Port
Connect a USB cable to this USB port to connect power to the device.
3
CART-Ring fixing
groove
Secure the CART-Ring in the CART-Ring fixing groove to charge the device.
4
LED indicator
When charging is in progress, the LED on the CART-Cradle lights up red. When
the Ring is fully charged, the LED turns green.
It takes about 2 hours to fully charge the CART-Ring. A fully charged Ring can
be used continuously for about 48 hours.

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.
If the LED on the CART-Ring or CART-Cradle blinks, the battery is not being charged. Check and confirm
that the charging orientation is correct, and charge the device.
10.4. LED indicator on the CART-Cradle
No.
Name
Details
1
Power is connected
When power is connected to the device using a USB cable, the LED indicator
lights up green for 1 second.
2
Charging is in
progress
When charging begins, the LED indicator lights up red.
3
Charging is
complete
When charging is complete, the LED indicator lights up green.
4
There is a charging
error
If there is a charging error, the LED indicator blinks red.

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.
11.3. Sign-up and Login
11.3.1. Sign-up
No.
Name
Details
1
Sign Up
If you do not have an account, tap “Sign Up” to proceed to sign-up.

11.3.2. Filling in the sign-up form
No.
Name
Details
1
ID
Tap the “ID” field and enter your email
address.
2
Password
Tap the “Password” field and set a password.
Set a strong password, to protect your
personal information.
3
Confirm
Password
Tap the “Confirm Password” field and enter
the set password again.
4
First
Name
Tap the “First Name” field and enter your first
name.
5
Last
Name
Tap the “Last Name” field and enter your last
name.
6
Sex
Tap the “Sex” field and select your gender.
7
Date of
birth
Tap the “Date of birth” field and select your
date of birth.
8
Location
Tap the “Location” field and select your
location.
9
Height
Tap the “Height” field and enter your height
(in cm).
10
Weight
Tap the “Weight” field and enter your weight
(in kg).
11
Agreeing
to all
terms and
conditions
Read and agree to the terms of service.
12
Sign Up
After filling in all required fields, tap “Sign
Up.” An email is sent to the email address
you provided, for user verification. Check the
email and complete user verification.
Note:
Ensure that your password is 10 to 20 characters long and alphanumeric, comprising "Upper, Lowercase
and Numerals."

11.3.3. Email Confirmation
No.
Name
Details
1
Resend Email
Verification
If a verification email has not been received, tap “Resend Email Verification” to
resend a verification email.
2
Login
Tap “Login” to log into the application.
Note:
If your account is already registered, a notification message appears and a user verification email is not
sent.

11.3.4. Login
No.
Name
Details
1
ID
Tap the “ID” field and enter your email address.
2
Password
Tap the “Password” field and enter your password.
3
Error message
An error message appears if you enter an incorrect ID or password.
4
Remember Me
To use the Auto Login feature, toggle the button that says “Remember Me” to the
right to enable the feature.
5
Login
Tap “Login” to log into the application.
6
Show password
Shows the password entered.

11.4. Changing password
1) If you forgot your password, tap “Forgot Password”.
No.
Name
Details
1
Forgot Password
Tap “Forgot Password” to navigate to the “Reset Password”screen.