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

13 Correct Aktiia bracelet positioning
Fasten your Aktiia bracelet around your wrist with the sensor facing toward the skin on top of the wrist. The clasp is on the
underside of the wrist. The sensor on the pod should be placed in direct contact with the skin. Tighten the bracelet to be
snug but comfortable to ensure that the bracelet does not move around while using your hands.
14 Correct Aktiia cuff positioning
The Aktiia cuff must be placed on the opposite arm with respect to the one wearing the bracelet (i.e., if you wear the Aktiia
bracelet on your RIGHT wrist, place the Aktiia cuff over your LEFT arm and vice versa).
1. Remove garments from your upper arm. If you roll up your sleeve, please ensure that the garment is not too tight.
2. Place your bare arm through the cuff to position the cuff 2-3 cm (1") above your elbow joint with the blue light closest to
your elbow.
3. Secure and tighten the cuff around your arm so that it fits closely but you can still insert two fingers between your arm
and the cuff. Please note that if the cuff is too loose, the measurement will not be accurate.
4. While seated, place your hand, palm side-up in front of you so that it is supported by a flat surface and the Aktiia cuff is
at the same height as your heart. Your Aktiia cuff is positioned on the inner side of your arm, over the artery.
Please check the Aktiia Init I1 user manual for instructions for use.
10 – EN

15 Body posture during the initialization procedure
Note : Blood Pressure measurements can be affected by the position of the cuff and your physiological and emotional condition.
1. Sit upright with your back straight and your feet flat on the floor. Do not cross your legs.
2. Place your hand palm-side down in front of you on a flat surface such as a desk or a table.
3. The middle of the Aktiia cuff should be placed at the same level as your heart.
4. Do not move or tense your arm muscles during measurement.
5. Relax, and do not move or talk.
11 – EN
Please sit down and relax for 5 minutes before starting the initialization procedure.

16 Accessing your data
Your Aktiia bracelet automatically tracks your blood pressure. Measurements are triggered every hour,
during the day and at night. We use a secured cloud server to store your data, not your Aktiia bracelet
or your phone. Therefore, visualizing your data in the Aktiia app requires a working internet connection
to synchronize with the Aktiia secure cloud server.
To sync your data
• Enable the Bluetooth and Internet connection on your mobile device. Depending on your Android
device version, the location service should be enabled as well.
• Open the Aktiia app to synchronize data from your Aktiia bracelet. The data synchronizes
automatically, with a sync indicator showing the status. Depending on how often you open the app
and synchronize your data, this might take a few seconds to several minutes.
• In case you do not see a sync view when opening the app, swipe down to manually activate
the synchronization.
• Make sure you open the app regularly so that the synchronization is fast, and you avoid losing data.
For this reason, synching once a day is recommended.
12 – EN

Visualizing your Blood Pressure data
• Use the Aktiia app to see your blood pressure data, every vertical line represents the average
measurements taken during the displayed period.
• The top endpoint of the line is the systolic (SYS) value, and the bottom endpoint of the line is the
diastolic (DIA) value.
• Tap on the line to read the numeric values, hold, and move your finger on the screen to navigate
through the values.
13 – EN

17 How to evaluate your Blood Pressure
The following classifications are based on measurements taken on a seated person after a few minutes of rest.
It is important to note that Blood Pressure readings in everyday life conditions might be higher.
The table is not intended to provide a basis for any type of diagnosis or emergency assessment; the table only depicts different classifications of blood pressure.
Consult your physician for an interpretation and diagnosis based on your personal blood pressure results.
14 – EN
The Aktiia app and devices are not intended to be diagnostic devices. Self-diagnosis of measurement results and self-treatment are potentially dangerous. You
should always consult your doctor for relevant interpretation of blood pressure results.

Europe
The European Society of Hypertension (ESH) has created the following guide for classifying blood pressure values.
BLOOD PRESSURE
CATEGORY
SYSTOLIC BP mmHg DIASTOLIC BP mmHg
COLOR
INDICATOR
OPTIMAL LESS THAN 120 AND LESS THAN 80 Dark green
NORMAL 120-129 AND/ OR 80-84 Light green
ELEVATED 130-139 AND/ OR 85-89 Yellow
HIGH BLOOD PRESSURE STAGE I 140-159 AND/ OR 90-99 Orange
HIGH BLOOD PRESSURE STAGE 2 160-179 AND/ OR 100-109 Light red
HIGH BLOOD PRESSURE STAGE 3 HIGHER THAN 180 AND/ OR HIGHER THAN 110 Dark red
Note : Various factors such as age, obesity and medical condition should be considered for a correct evaluation.
Consult with your physicians for an accurate assessment and diagnosis of your health condition.
15 – EN

18 Battery handling and power supply
The battery of the Aktiia bracelet is a built-in rechargeable li-polymer battery. Access the current charge of your bracelet via the Aktiia app.
If the battery is lower than 10%, please charge your device:
1. Connect the USB microB connector (the smaller side) of the USB cable to the provided charging station’s port.
2. Connect the USB A connector (the larger side) of the USB cable to a power source.
3. Place the Aktiia bracelet on the charging station as shown below. The red light on the bottom part of the charger will start glowing.
4. A steady red light indicates that the device is fully charged.
It is recommended that you charge the battery when the battery is less than 10%.
The Aktiia bracelet charger is designed to work when connected to a constant 5V DC source.
.
Note : The battery life and charge cycles vary by use and settings.
16 – EN
The battery in this device is a fixed battery and can only be changed by an
authorized Aktiia Service agent.
Should your battery be defective, please contact Aktiia Customer Service for a
replacement. Lithium battery replacement by inadequately trained personnel could
result in a hazard such as a fire or explosion.

19 Unpair your device
Aktiia bracelet is designed for personal use (single user) only. The in-app pairing process links
your device to your account. Suppose you wish to allow another person to use the Aktiia bracelet.
In that case, you must unpair the devices from your Aktiia account.
To complete the unpairing procedure you should:
1. Login to your account
2. Tap on the device tab
3. Tap on the button with the three dots
4. Press unpair
Note : Unpairing is needed if the Aktiia bracelet and/or the Aktiia cuff are to be linked with a new user account.
Note : Unpairing is not needed if a new mobile device is used to download the same user account's Aktiia data.
17 – EN

20 Troubleshooting
The Aktiia bracelet is designed to be discreet, with no lights or alarms bothering you during your daily life.
To know if your Aktiia bracelet is ON :
1. Take off your Aktiia bracelet.
2. Look at the sensor on the bottom side of the Aktiia bracelet.
3. Double tap the side of the pod (either side is fine), a green light should blink within 5 seconds.
If the green light does not blink, your Aktiia bracelet may be out of power.
Please charge your device with the provided charging station.
18 – EN
Problem Solution
I don’t see a red light when charging
my Aktiia bracelet
Verify that the charging station is well connected to a power supply through the USB cable provided.
Try replacing the Aktiia bracelet by turning it through 180°. The charging pins on the pod should be aligned
with the ones on the charging station. The pod should be magnetically locked on the charging station.

My Aktiia bracelet does not connect to
my mobile device
Check that your mobile device Bluetooth is activated and that you enabled permissions for
Bluetooth connection and location.
If your mobile device Bluetooth is activated but your Aktiia bracelet still does not connect,
place your Aktiia bracelet on the charging station to force a reset (you will not lose your personal data
or account information). If the problem persists, contact Aktiia Customer Service.
I cannot sync my Aktiia bracelet with the
Aktiia app
Check that your Aktiia bracelet is connected in the Devices section.
On the Home screen pull down to activate on demand syncing.
I cannot pair my Aktiia bracelet with the
Aktiia app
Verify that your Aktiia bracelet is correctly placed on the charger and that a red light is visible
at the bottom of the charging station.
The initialization recording failed
Verify that Bluetooth and Location services are enabled, and the devices are connected. Verify that you
have a stable internet connection.
Verify that the Aktiia bracelet and Aktiia cuff are positioned correctly.
Take 5 deep breaths before starting the initialization procedure again, and make sure not to move during
recording.
The Aktiia bracelet was not found Place your Aktiia bracelet on the charging station and connect it to the power supply.
Verify that Bluetooth is on and permissions are granted and try again.
There is no reliable measurement data
for this period
The Aktiia bracelet only measures your blood pressure while you are at rest. You might not get any
measurements during periods of high activity. Please get in touch with our customer support if you don't
get any measurements for more than 24 hours and other troubleshooting steps do not resolve this.
19 – EN