SkyLabs CART-I Manuel utilisateur

◆Contents 
 
Device Description & Intended Use ..........................................................................................................................5
Packages......................................................................................................................................................................5
Device Specifications .................................................................................................................................................6
1. Intended use and/or indications for use.........................................................................................................6
2. Product information..........................................................................................................................................6
3. General product information ...........................................................................................................................6
4. Device Specifications .......................................................................................................................................7
Environment specification .........................................................................................................................................8
Symbols .......................................................................................................................................................................9
Safety Precautions ....................................................................................................................................................10 
1. Safety information ..........................................................................................................................................10 
2. Limitation of use .............................................................................................................................................10 
3. General safety / warnings ..............................................................................................................................10 
4. Precautions/warnings for reading Heart rates and ECG (how to collect signals) ...................................10 
5. Product management .....................................................................................................................................11 
6. Radio frequency / Electromagnetic field / Environment .............................................................................11 
7. Maintaining water and dust resistance......................................................................................................... 11 
8. Intended use....................................................................................................................................................12 
9. Disposal of the device and/or battery in accordance with local environmental laws and guidelines. ..12 
Contraindications......................................................................................................................................................13 
Disposal .....................................................................................................................................................................13 
Quality Assurance and Limited Warranty...............................................................................................................13 
Installation & Charging...........................................................................................................................................13 
1. Installation (app download) .........................................................................................................................13 
2. How to charge CART-Ring ...........................................................................................................................13 
3. How to place (and charge) CART-Ring on the CART-Cradle....................................................................14 
4. LED Indicator of CART-Cradle.....................................................................................................................14 
1. Preparation before use .................................................................................................................................15 
1. Product installation & registration ..............................................................................................................15 
3. How to sign up/log in....................................................................................................................................15 
4. Forgot password ...........................................................................................................................................17 
5. Register CART (CART-Ring) ........................................................................................................................18 

6. Measure..........................................................................................................................................................19 
7. Report (by Period).........................................................................................................................................21 
8. History (previously - measured self - check records) ...............................................................................23 
9. Setting ............................................................................................................................................................24 
10. Android device application “Optimize battery usage” not used (iOS not applicable).........................30 
11. How to manage/store the CART while not in use ....................................................................................30 
Information on EMC ................................................................................................................................................30 
1. Guidance and Manufacturer's Declaration (electromagnetic emissions)...............................................30 
2. Guidance and Manufacturer's Declaration (electromagnetic Immunity) ................................................30 
FCC Compliance Statement ...................................................................................................................................33 
Troubleshooting and Update .................................................................................................................................34 
1. Self-check ......................................................................................................................................................34 
2. General (CART-App) .....................................................................................................................................34 
Label .........................................................................................................................................................................34 
1. Labelling Position of CART-Ring ................................................................................................................34 
2. Labelling Position of CART-Cradle .............................................................................................................35 
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:

info@skylabs.io

Tel.:

+82-1599-3402

EC Representative:

CE Medical

Address:

#Amerlandseweg 7, 3621ZC, Breukelen, the Netherlands

Website:

http://www.ce-mark-medical.com

E-mail:

info@ce-mark-medical.com

Tel.:

+31 (0)85 007 3220

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

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