Aktiia Bracelet G1 User manual

Bracelet G1
EN – User Manual
FR – Manuel d’utilisation
DE – Bedienungsanleitung
IT – Manuale d’uso ENGLISH

Content
Introduction
2
Warranty
20
Intended purpose
2
Specifications
21
Indications for use
3
EMC and RF statements
23
Contraindications
3
Electromagnetic compatibility information
24
Intended population
3
Compliance
27
Intended clinical benefits
4
Disposal
28
Technological characteristics
4
Network security recommendations
29
Important safety information
5
Safety symbols definitions
30
Package contents
6
Operating requirements
7
Authorized and compatible devices
7
Set up and initialization procedures
8
Correct Aktiia bracelet positioning
10
Correct Aktiia cuff positioning
10
Body posture during the initialization procedure
11
Accessing your data
12
How to evaluate your Blood Pressure
14
Battery handling and power supply
16
Unpair your device
17
Troubleshooting
18
Care and maintenance
20
1 – EN

1 Introduction
The Aktiia Bracelet G1 is the smart way to track your Blood Pressure over days and nights without any effort. The Aktiia Bracelet G1 is designed to be
discreet, with no lights or alarms bothering you during your daily life. With its accuracy and ease of use, Aktiia is the perfect solution to track your blood
pressure 24 / 7.
Aktiia offers a new way to monitor your heart health that easily integrates into your life. Our device tracks your Blood Pressure through unnoticeable
measurements performed multiple times per day. All you need to do is to wear the bracelet. You can access your data anytime by simply looking at the
Aktiia mobile application.
Please read this User Manual carefully to gain a complete understanding of the device’s functions and safety-related information.
Support : In case you have any additional questions, you encounter any issue, or you would like to suggest some improvements, please contact Aktiia’s
Customer Service at suppor[email protected] or visit our website at www.aktiia.com.
Incident and Adverse Event : For any incident or event, please contact immediately Aktiia at [e-mail] with mention of Incident or Adverse
Event in the email content or title.
2 Intended purpose
Aktiia Bracelet G1 is a non-invasive blood pressure (BP) monitor intended to measure optical Photoplethysmography (PPG) signals on the user’s wrist and to
calculate blood pressure values using a Pulse Wave Analysis (PWA) technique, following a calibration process using an oscillometric blood pressure monitor.
Aktiia Bracelet G1 can also calculate heart rate based on the same measurement and analysis technology.
2 – EN

3 Indications for use
The Aktiia Bracelet G1, referred to as the Aktiia bracelet, is indicated for monitoring of adult patients for home use only.
4 Contraindications
The Aktiia bracelet IS NOT INTENDED to be used :
• on patients suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia
(heart rate at rest > 120bpm) and atrial fibrillation;
• on patients suffering from pathologies that systematically reduce peripheral perfusion including Raynaud’s disease, diabetes, renal dysfunctions
(eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula;
• on pregnant women;
• on damaged / injured skin;
• on patients below 21 y.o. and above 85 y.o.
5 Intended population
The Aktiia Bracelet G1 is intended to be used on and by adult population, aged between 21 and 85 years old. There are no restrictions related to the user’s sex
and ethnicity.
3 – EN

6 Intended clinical benefits
The Aktiia system enables long-term unbiased blood pressure and heart rate monitoring. This clinical benefit to the user stems from the acceptable accuracy,
stability and automaticity of the blood pressure and heart rate estimation in compliance with the requirements of the relevant standards, ISO 81060-2 Non-
invasive sphygmomanometers -- Part 2: Clinical investigation of intermittent automated measurement type and 80601-2-61 Medical electrical equipment - Part 2-
61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Aktiia Bracelet does not provide any diagnosis of your blood pressure.
Consult your physician for an appropriate analysis of your blood pressure data for diagnosis.
7 Technological characteristics
The Aktiia bracelet uses PPG technology (Photoplethysmography) to acquire optical data on your wrist. The PPG data are then transferred through the Aktiia
mobile application to a secured cloud server on which Aktiia’s algorithms estimate your blood pressure through advanced processing of the optical data. The
Aktiia bracelet detects if the user is moving before initiating a PPG measurement and will provide blood pressure measurement only when the user is still.
This product is licensed under patents owned by CSEM SA, Switzerland.
4 – EN

8 Important safety information
Please read the important safety information in this user manual before using the device. Any serious incident occurring in relation to the Aktiia bracelet
should be reported to Aktiia and the competent authority of the Member State in which the user and / or patient is established.
Warning and Caution symbols definition:
Symbol
Definition
Symbol
Definition
The “WARNING” sign in this user manual indicates
a potentially hazardous situation which, if not
avoided, could result in serious injury or death.
The “CAUTION” sign in this user manual indicates a potentially hazardous
situation which, if not avoided, could result in minor injury to the user or
patient or damage to the equipment or other property.
Important safety information, including residual risk and side effect, about Aktiia Bracelet:
Important warning information:
A risk of swallowing and suffocation has been identified as residual risk: The pod on your Aktiia bracelet is small enough to be swallowed by a young child.
To prevent risk of suffocation, never leave your Aktiia bracelet unattended!
No modification of the equipment is allowed.
Important caution information:
This device may only be used for the purposes described in this User Manual. Aktiia cannot be held liable for damage or injury caused by incorrect use. Always
follow the operating procedures described in this User Manual to measure your blood pressure accurately and safely.
Aktiia Bracelet is designed as a device for personal use (single user) only.
Do not share your device with others as it may result in inaccurate blood pressure readings.
The strap of your Aktiia Bracelet contains silicone material. A side effect of skin irritation and reaction has been identified.
Avoid wearing the Bracelet in case of known allergy to silicone. In case of skin irritation or reaction, stop wearing your Aktiia Bracelet immediately and consult your
doctor.
5 – EN

9 Package contents
Make sure to remove all components from the packaging and inspect for damage. If the Aktiia packaging or any other components are damaged, do not use
and contact Aktiia's Customer Service. Your Aktiia bracelet is supplied in a box containing the following items :
1 Aktiia Bracelet G1 with pod and strap
1 Charging station +
1 USB cable
1 User Manual
Latest version of Aktiia Bracelet user manual can also be found online at :
www.aktiia.com/ifu
Note : If the packaging or any other components are damaged, do not use and please contact Aktiia Customer Service.
6 – EN

10 Operating requirements
To use the Aktiia bracelet you need to download the free Aktiia mobile application (Aktiia app) from the Apple App Store or Google Play.
Creation of a user account via the Aktiia app is required to make use of the Aktiia bracelet.
Access to the Internet is required to:
• Download the Aktiia app
• Create and access your Aktiia user account
• Update the Aktiia device firmware
• Visualize your new Blood Pressure data
• Receive insights on your Blood Pressure readings
11 Authorized and compatible devices
Your Aktiia bracelet requires initialization and periodic reinitialization. This procedure must be realized with an authorized compatible device, the Aktiia Init I1 -
referred to as the Aktiia cuff. The Aktiia cuff is an oscillometric blood pressure monitor provided by Aktiia in a separate package.
7 – EN

12 Set up and initialization procedures
1. Charge the Aktiia bracelet and the Aktiia buff before first use.
Connect the provided charging station to a USB port using the charging cable and place the Aktiia bracelet on the charging station,
making sure to remove the plastic cover from the bottom of the Aktiia bracelet. A red light at the bottom of the charger will start
glowing. When the charge is completed, the indicator light stays a steady red color.
To charge the Aktiia Cuff, please refer to the provided Aktiia Init I1 user manual for operating information.
2. Download the Aktiia app.
Scan the QR code or go to the Apple App Store or Google Play to download and install the Aktiia app.
3. Create a user account on Aktiia app.
Open the Aktiia app on your mobile device and follow the instructions to register and set up your personal account.
4. Pair your Aktiia bracelet with your mobile device.
Place the Aktiia bracelet on the charging station, follow the on-screen instructions to enable the appropriate permissions and to pair with your mobile device.
Wait until pairing is confirmed by Aktiia app.
5. Pair your Aktiia cuff with your mobile device.
Unplug the Aktiia cuff from the charging cable and power ON using the toggle switch. When a blue light begins to blink, follow the cuff pairing instructions in
the Aktiia app.
8 – EN

6. Fit your Aktiia bracelet on your wrist.
Follow the Aktiia app on-screen instructions or carefully read the instructions in the “Correct Aktiia bracelet positioning” section (§12) of this user manual.
7. Fit your Aktiia cuff on the opposite arm.
Follow the on-screen instructions, noting the Aktiia cuff must be placed on the opposite arm as the Aktiia bracelet, i.e., if you wear the Aktiia bracelet on your
RIGHT wrist, place the Aktiia cuff over your LEFT arm and vice versa.
The accuracy of blood pressure measurement done by Aktiia Cuff depends on the correct Cuff positioning.
Please carefully read the instructions in the section “Correct Aktiia Cuff positioning” (§13) of this user manual.
8. Initialize your Aktiia bracelet.
In the Aktiia app, carefully follow the instructions to complete the initialization procedure. The Aktiia cuff will start inflating.
9. Switch OFF your Aktiia cuff.
The accuracy of the initialization process depends on your body posture during the initialization. Carefully read the section “Body Posture during
Initialization Procedure” (§14) of this user manual.
Congratulations! Your Aktiia bracelet is now initialized and ready to track your blood pressure!
You need to complete an initialization procedure at least once per month, or when prompted by the mobile application. Data obtained outside the
initialization period may be inaccurate.
9 – EN