Aktiia Bracelet G1 User manual

Bracelet G1
EN– UserManual

1 – EN
Content
Introduction 2
Intended purpose 2
Indications for use 3
Contraindications 3
Clinical benets 3
Technological characteristics 4
Important safety information 4
Package contents 6
Operating requirements 7
Authorized accessories 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
Warranty 20
Specications 21
EMC and RF statements 23
Electromagnetic compatibility information 24
CE compliance 27
Disposal 28
Network security recommendations 29
Safety information 30

2 – EN
1 Introduction
Aktiia Bracelet is the smart way to track your Blood Pressure over days and nights without any effort. Aktiia Bracelet 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 app.
Please read this User Manual carefully to gain a complete understanding of the device’s functions and safety-related information.
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 [email protected] or visit our website at www.aktiia.com
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.

3 – EN
3 Indicationsforuse
Aktiia Bracelet G1 is indicated for monitoring of adult patients in home use.
4 Contraindications
Aktiia Bracelet G1 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 brillation;
• 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 stula;
• on pregnant women;
• on damaged / injured skin;
• on patients below 21 y.o. and above 65 y.o.
5 Clinicalbenets
Aktiia Bracelet G1 enables long-term unbiased blood pressure monitoring (e.g. free from whitecoat effect, masked hypertension effect).
Aktiia Bracelet G1 does not provide any diagnosis of your blood pressure.
Consult your physician for an appropriate analysis of your blood pressure data for diagnosis.

4 – EN
6 Technologicalcharacteristics
Aktiia Bracelet uses PPG technology (Photoplethysmography) to acquire optical data on your wrist. The PPG data are then transferred through the Aktiia App
to a secured cloud server on which Aktiia’s algorithms estimate your blood pressure through advanced processing of the optical data. 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.
7 Importantsafetyinformation
Please read the important safety information in this user manual before using the device. Any serious incident occurring in relation to Aktiia Bracelet
should be reported to Aktiia and the competent authority of the Member State in which the user and / or patient is established.
Warnings
The“WARNING”signinthisusermanualindicatesapotentiallyhazardoussituationwhich,
ifnotavoided,couldresultinseriousinjuryordeath.
Your Aktiia Bracelet Pod is small enough to be swallowed by a young child.
To prevent risk of suffocation, never leave your Pod unattended !
No modication of the equipment is allowed.

5 – EN
Cautions
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.
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. Avoid wearing the Bracelet in case of known allergy to silicone.
In case of skin irritation, stop wearing your Aktiia Bracelet immediately and consult your doctor.

6 – EN
1AktiiaBracelet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
8 Packagecontents
Your Aktiia Bracelet is supplied in a box containing the following items :

7 – EN
9 Operatingrequirements
In order to use Aktiia Bracelet you need to download the free Aktiia app from the Apple App Store or Google Play.
Creation of a user account and login are requested to operate Aktiia Bracelet.
Access to the Internet is required to :
• Download the Aktiia App;
• Set up your Aktiia user account;
• Update Aktiia Monitor’s rmware;
• Visualize your new Blood Pressure data;
• Receive insights on your Blood Pressure readings
10 Authorizedaccessoriesandcompatibledevices
Your Aktiia Bracelet G1 requires initialization and periodic re-initialization. This procedure must be realized with an authorized compatible accessory
referred to in this manual as Aktiia Cuff. Aktiia Cuff is an oscillometric device provided by Aktiia in a separate package.
Aktiia Bracelet works with mobile devices operating and Wi- or 3G / 4G / 5G connection.
For more details on the authorized accessories and compatible devices, please refer to www.aktiia.com/support/compatible_devices.

8 – EN
11 Setupandinitializationprocedures
1. ChargeBraceletbeforeFirstUse.
Connect the charging station to a USB port using the charging cable provided, and place Aktiia Bracelet on the station.
A red light at the bottom of the charger will start blinking. When charge is completed, the indicator light is a steady red color.
2. DownloadAktiiaApp.
Scan the QR code on this page or go to the Google Play store or Apple App Store, then 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 Aktiia Bracelet on the charging station and enable Bluetooth connection on your mobile device. Wait until pairing is conrmed by Aktiia App.
5. PairyourAktiiaCuffwithyourmobiledevice.
Switch ON the Aktiia Cuff by acting on the toggle button. A blue light should start blinking. Wait until pairing is conrmed by Aktiia App
and the light indicator is a steady blue. For further information on Aktiia Cuff operation, please refer to its user manual.
6. FityourAktiiaBraceletonyourwrist.
For optimal measurement by Aktiia Bracelet, please carefully read the instructions
in the “Correct Aktiia Bracelet positioning” section of this user manual.

9 – EN
7. FityourAktiiaCuffontheoppositearm.
Aktiia Cuff must be placed on the opposite arm with respect to the one wearing the Bracelet
(i.e if you wear Aktiia Bracelet on your RIGHT wrist, place the Cuff over your LEFT arm and vice versa).
The accuracy of blood pressure measurement done by Aktiia Cuff depends on the right Cuff positioning.
Please carefully read the instructions in the section “Correct Aktiia Cuff positioning” of this user manual.
8. InitializeyourAktiiaBracelet.
On the Aktiia App, carefully follow the instructions on the screen to start the initialization procedure. The Cuff will start inating.
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” 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, when prompted by the mobile application.
Data obtained outside the calibrated period may be inaccurate.