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

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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.

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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.

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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.

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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.

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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 :

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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.

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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.

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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.

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12 CorrectAktiiaBraceletpositioning
Make sure to wear your Aktiia Bracelet on the side of your wrist bone that is closer to your forearm
(rather than closer to your hand). This ensures that the Bracelet does not move around as much when
you are using your hands. The sensing side of the pod should be placed in direct contact with the skin,
on the top side of the wrist. The Bracelet should be snug but comfortable.
13 CorrectAktiiaCuffpositioning
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).
1. Remove garments from your upper arm. If you roll up your sleeve, please ensure that the garment is not too tight
so that it does not cause any blood ow constriction.
2. Place your bare arm through the Cuff and position the Cuff 1" (2-3 cm) above your elbow joint.
3. Tighten the Cuff around your arm so that it ts closely but you can still insert two ngers between your arm and the Cuff.
Secure the Cuff closed with the Velcro fastener.
4. While seated, place your hand, palm side-up in front of you so that it is supported by a at surface and the Aktiia Cuff is at the same height as your heart.
Your Aktiia Cuff monitor is positioned on the inner side of your arm, over the artery and the logo is at its top.
Please check the instructions for use provided with the
Aktiia Cuff calibration accessory (see §10)

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14 Bodypostureduringtheinitializationprocedure
Please sit down and relax for 5 minutes
before starting 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 at on the oor.
2. Place your hand palm-side up in front of you on a at surface such as a desk or a table.
3. The middle of the Cuff should be placed as the same level as your heart.
4. Do not move or tense your arm muscles during measurement.
5. Relax, and do not talk.

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15 Accessingyourdata
Your Aktiia Bracelet automatically tracks your blood pressure. Measurements are triggered every hour,
at day and at night. To ensure optimal data security, your data are not stored on Aktiia Bracelet or on
your phone but on a secured cloud server. Visualizing your data in Aktiia App therefore requires internet
connection in order to synchronize with Aktiia secure server.
Syncing your data
• Make sure Bluetooth and Internet connection on your mobile device are enabled.
If you have an Android device, your location service should be enabled as well.
• Open the Aktiia App to synchronize data from your Aktiia Bracelet. The synchronization is done
automatically and a sync view at the top of the screen shows you the sync status.
This might take few seconds to several minutes depending on how often you open the app
and synchronize your data.
• 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.

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Visualizing your Blood Pressure data
• Press the Home button on the Aktiia App to see your blood pressure data in a chart format.
• Every vertical line represents the average of the 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 nger on the
screen to navigate through the values.
• The average Blood Pressure values for the day are shown at the top of the screen.
• Tap the left and right arrows or swipe left and right to navigate through your historical data.

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16 HowtoevaluateyourBloodPressure
Aktiia monitor is not intended to be a diagnostic device. Self-diagnosis of measurement results and self-treatment
are potentially dangerous. You should always consult your doctor for relevant interpretation of blood pressure results.
The following classications are based on measurements taken on a seated person after few minutes of rest.
It is important to note that Blood Pressure read-ings in normal life conditions might be higher.
These charts are not intended to provide a basis for any type of diagnosis or emergency assessment;
these charts only depict different classications of blood pressure.
Consult your physician for an interpretation and diagnosis based on your personal blood pressure results.

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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.
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
Europe
The European Society of Hypertension (ESH) has created the following guide for classifying blood pressure values.

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17 Batteryhandlingandpowersupply
The battery of Aktiia Bracelet is a built-in rechargeable li-polymer battery.
When the monitor is connected to a mobile device, the battery volume will be displayed in the mobile app, in the Devices section.
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 charger’s USB connector port.
2. Connect the USB A connector (the larger side) of the USB cable to a power source.
3. Place Aktiia Bracelet on the charger as depicted below.
A red light on the bottom part of the charger starts blinking when the monitor is charging.
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%.
Aktiia Bracelet charger is designed to work when plugged to a constant 5V DC source.
The battery in this device is a xed 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 re or explosion.
Note : Battery life and charge cycles vary by use and settings.

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18 Unpairyourdevice
Aktiia Bracelet G1 is designed for personal use (single user) only.
During the pairing procedure, the devices are linked to your account. In case you wish to reset the pairing
and allow another person to use the device you must reset the pairing rst.
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 Aktiia Bracelet and / or Aktiia cuff need to be linked with a new user account
Note : Unpairing is not needed if a new mobile device is used to download Aktiia data with the same user account

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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 Pod by turning it by 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.
19 Troubleshooting
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 pod.
3. Double tap the side of the pod (either side is ne), a green light should blink within 5 seconds.
If the green light does not blink, your Aktiia Bracelet may be out of power.
Please put your device on the charging station.

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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 app Check that your Aktiia Bracelet is connected in the Devices section.
On the Home screen scroll down to activate Sync.
I cannot Pair my Aktiia Bracelet 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.
Initialization recording failed
Verify that Bluetooth and Location services are enabled, and devices are connected.
Verify that you have a stable internet connection.
Verify that the Aktiia Bracelet and Aktiia Cuff are positioned correctly.
Do not move during recording and take 5 deep breaths before starting the initialization procedure again.
Aktiia 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
Aktiia Bracelet only measures your Blood Pressure while you are at rest. You might not get any
measurements during periods of high activity. If you don’t get any measurements over more than 24 hours,
and other troubleshooting steps do not resolve this, please contact our customer support.