Product

Each box contains an Aktiia bracelet, initialisation cuff, charging base, USB cable and user manual.

We take data security seriously, especially when it comes to protecting your personal data. We use 256 bit Advanced Encryption Standard (AES-256) and Transport Layer Security (TLS) for all communications between Aktiia Bracelet and mobile application.

The Aktiia bracelet is not a simple consumer wearable device such as a step counter of a fitness tracker. The Aktiia bracelet is a medical device that has undergone extensive and thorough clinical validation. During the development of the technology used in the Aktiia bracelet two clinical trials have been conducted that have demonstrated that its accuracy is comparable to that of a regular cuff that you would place on your upper arm. In particular, our medical device has been validated in patients representing the general population, according to the ISO-80601-2 international standard. To learn more about our clinical trials please visit the Evidence section on our website.

Please refer to the evidence section on our website.

Aktiia has been validated in multiple clinical trials according to ISO-80601-2 standards and has received the CE marking as a Class IIa medical device. For additional information please refer to the evidence section on our website.

The Aktiia Bracelet is water-resistant.  It can be exposed to water spray like rain and perspiration.  It should not be immersed in water and do not expose the Aktiia bracelet to water moving with force, such as water running from a tap, ocean waves, or waterfalls.

Yes, you can wear the bracelet on both wrists. We recommend that you wear the bracelet on your non-dominant wrist as you move it less and you thus maximise the chances of obtaining reliable measurements.

In the Aktiia mobile application, you can download a summary report in pdf format and share it with your doctor. To download your report you should go to the profile screen and press the Generate Report button.

No. Aktiia has been tested on a broad range of individuals with different follicular densities.

Please remove your bracelet and wait a few days until the skin is repaired before wearing it again. To avoid this kind of issues please do not wear your bracelet under the shower or during intense physical activity and clean it regularly. If the symptoms persist, please consult your physician.

Simply wipe your Aktiia Bracelet with a soft cloth lightly moistened with water. Then dry your Aktiia Bracelet with a dry cloth.

To ensure accurate readings, the Aktiia bracelet is designed to take measurements only during resting periods. Through the use of an accelerometer to gauge movement, the Aktiia bracelet will automatically determine if an accurate measurement can be taken.

No, the Aktiia bracelet should be used by only one person at a time and every user should have his/her own account.

The cuff can accommodate arms with a circumference between 22 and 42 cm. At this time we only offer one size of cuff.

Aktiia bracelet should be reinitialised at least once a month. If the initialisation is not performed within the required date, accuracy cannot be ensured. We display a disclaimer saying that the data might not be accurate in case the initialisation was not performed in due time.

The Aktiia solution has been validated via clinical trials and received CE Mark clearance for users within the age group 21-65, excluding contraindications due to certain health conditions. Please refer to the user manual for a full list of contraindications.

Aktiia is in the process of conducting additional research to expand our intended user population.

At this time, we have one size of the bracelet that fits wrists with circumferences between 14 cm and 21 cm.  We are working on creating a longer band and expect to have made it available in several months.

Initialisation

Aktiia bracelet indirectly estimates blood pressure changes through optical means. In order to provide absolute values of blood pressure in units of mmHg, an initialisation with a reference value is needed. The reference measurement has to be taken with the initialisation cuff, which is a validated sphygmomanometer device like most standard blood pressure cuffs.

The cuff should be worn on your left arm.

No, the wrist you wear the bracelet on will not have any impact.

No, you can perform a new initialisation whenever you want to by clicking on the devices tab in the mobile app and pressing on the “Update Initialisation” button. You should update the initialisation at least once per month.

The initialisation has an impact on the absolute values but not on the variations of blood pressure over time. We recommend that you take the initialisation strictly following the guidelines. You should relax for 5 minutes before taking a new measurement.

Please follow the instructions in the Aktiia app carefully, do not talk or move during the process and remember to;

Check your bracelet positioning and readjust if needed:

  • The bracelet is on the elbow side of your wrist bone and on the top side of your wrist.
  • The bracelet is on the opposite arm of the cuff.
  • The bracelet is in contact with your skin. It fits snugly but it is comfortable.
  • The bracelet is not too tight, you can lift it from your wrist.

Check your cuff positioning and readjust if needed:

  • Ensure the cuff is on your bare skin about 2cm above the elbow.
  • Do not wear the cuff on top of your garments.
  • Do not roll up your sleeve as it could affect the blood flow in your upper arm.

Check your arms position and readjust if needed:

  • Your entire forearm, from hand to elbow is resting on a flat surface.
  • Your forearm is not leaning against the table edge to avoid constriction on the brachial artery.

If you have troubles passing the initialisation do not retry immediately after failure but instead, come back after a few hours. If after three independent attempts you still have difficulties passing the initialisation, please contact our support team at My frie

Connection - Pairing

Aktiia supports iPhones running iOS 11 or newer and Android devices running 7.0 or newer.

Aktiia uses Bluetooth Low Energy (BLE) connectivity to transfer data between the bracelet and the mobile application running on a smartphone.

No, the measurements are stored in the bracelet memory and the Bluetooth connection is only needed to download the data from the bracelet to your smartphone. We recommend that you synchronise your data multiple times per day to best track your daily blood pressure pattern.

Please check that your smartphone model and operating system are compatible with the Aktiia bracelet:

  • iOS App compatible with iOS 11 or later.
  • Android app compatible with Android 8 or later.
  • Bluetooth 4.2 or newer.

Please check that your bracelet is correctly positioned on the charging station. You should see a red-light blinking (or steady if the bracelet is fully charged) at the bottom of the charger. Please try removing and replacing the bracelet on the charger and try again. In case you see the message “This device is already paired” please contact support at support@aktiia.com

Please check that your smartphone model and operating system are compatible with Aktiia Int I1 (cuff):

  • iOS App compatible with iOS 11 or later.
  • Android app compatible with Android 8 or later.
  • Bluetooth 4.2 or newer.

Please check that your cuff is switched on, you should see a blue LED blinking. In case you see the message “This device is already paired” please contact support at support@aktiia.com

No, Aktiia mobile application is not designed to work with tablet devices or smartwatches at this time.

All your data are processed and securely stored in our cloud server. In order to access your data, you need to have a stable internet connection

Contact support at support@aktiia.com

Data Protection

We take data security seriously, especially when it comes to protecting your personal data. We use 256-bit Advanced Encryption Standard (AES-256) and Transport Layer Security (TLS) for all communications between Aktiia Bracelet and mobile application.

 

 

All your data is stored on Aktiia’s secure cloud server, located in Europe. Our data policy is compliant with GDPR regulations. You can find more information on our privacy policy

You can retrieve all your data by sending a written request by email to support@aktiia.com with the subject “Personal data download”.

Blood Pressure Data

You may see empty data slots during the hours of the day that you have high physical activity. Aktiia bracelet performs optical measurements on your wrist throughout the day and the night. However, when you are performing continuous high movements of your hands the movement artefacts you generate pollute the optical readings and might compromise the reliability of the blood pressure readings. Other reasons for missing data points might be due to the bracelet being worn too tight or too loose or there is a decreased flow of blood to your wrist (this happens for instance when you are feeling cold).

As accuracy is our top priority when the bracelet detects wrist movements, it switches off the sensing modules, and you will see an empty slot in the Aktiia App. The device will do its best to catch your next quiet period to measure again and continue filling in data slots. Simply continue using the device as you will have more chances to get Blood Pressure readings into the App.

Aktiia bracelet was not able to take a measurement during the indicated time slot. Aktiia bracelet only takes measurements during periods when it has high confidence it will obtain an accurate reading. If you are performing physical activities or are moving your wrist Aktiia bracelet will not take any measurement. Other reasons for missing data points might be the bracelet is worn too tight or too loose, there is a decreased or flow of blood to your wrist (this happens for instance when you are feeling cold).

Blood pressure is not a constant number and it continuously changes during the day and the night.

Whenever you have performed a pressure reading with a regular cuff it was not simultaneous with the Aktiia reading you see in the App: therefore, these measurements are different. Even by managing to perform simultaneous readings with another device, you must be aware that regular cuffs provide pressure readings with a significant error margin.

85% of the readings with a regular cuff have an error that is contained within ± 10 mmHg, the remaining 15% of readings have errors that even larger, and this can be even worse if your device was worn at the wrist or it is not a validated device.

Therefore, blood pressure measured by two devices can largely diverge, and the only scientifically grounded manner to validate the accuracy of a device is to perform thorough clinical trials that follow international validation standards. You can find more about the clinical trials that supported the commercialisation of Aktiia on our dedicated page here

Battery

Check that your charger is connected to a power supply with the provided USB cable. Ensure that the bracelet is correctly positioned on the charging station, you should hear a “click” sound and feel the magnetic attraction.

Your bracelet is fully charged when the red light of the charger stops blinking. You can check the bracelet battery status on your app in the Devices tab.

The battery should last up to 9 days.

Up to 2 hours are needed to charge the Aktiia bracelet. When the charging process is completed the red light at the bottom of the charger should become steady.

Aktiia Account

To delete your account you should go to the Profile section on your app and tap on the “Settings” button. At the bottom of the screen, you will find the “Deactivate account” button. This allows you to delete your account and all your personal data. Please note that this action is not reversible.  If you have signed up for one of our monthly subscription options,  you will continue to be charged a monthly fee until your contractual commitment has been fully satisfied.

 

Check your spam folder for Aktiia’s confirmation email. If no confirmation email is found please try registering again to check if the email address was correctly inserted.

Orders, Shipping and Returns

Aktiia has a 14-day return policy. We are committed to your satisfaction. If you are not completely satisfied with your product for any reason, just reach out to us at support@aktiia.com.

Aktiia warrants that your product is free from defects in materials or workmanship for a period of two (2) years from the date of delivery of the Aktiia product.

Contact customer support by emailing support@aktiia.com and indicate that you would like to use your right to withdraw.

Please note that only forms completed within the 14 days withdrawal period will be accepted. The proof of purchase from aktiia.com/uk should be included. Products not returned in their original packaging (all components must be included in the return)  or not in their original condition will not qualify for a refund. Refunds will be made in the form of the original payment.

We are only accepting orders and shipping to the U.K, Ireland, Switzerland, Germany, Austria and France. To get updates on when the product may be available in your country please sign up for our International newsletter.

To cancel your pre-order, please email us at orders@aktiia.com

Any modification done on billing or shipping address from your Aktiia account will register the data only for future orders. If billing or shipping details need to be modified for an ongoing order, contact orders@aktiia.com

No, prices shown on the website are inclusive of fees and taxes.

Billing and Subscription

Aktiia provides a solution that is not just a standalone wearable device. Aktiia provides a full Medical Service to continuously monitor your blood pressure, day, and night. The components of the solution are the bracelet, cuff, and the Aktiia App; these connect to our cloud-based service to enable 24/7 blood pressure monitoring. This full solution is what we mean by “Aktiia 24/7 Blood Pressure Monitoring Service.”

You can purchase 1 year 24/7 Monitoring Service for £199.99. You will receive all components of the system (bracelet, cuff, app) for the first year. After the first year, if you wish to continue using the 24/7 Monitoring Service, you will be charged a monthly fee of £6.99. If you choose not to proceed, you will be able to keep the hardware, but the full service will not be functional unless you decide to re-start your subscription in the future

If you have purchased a one-year subscription, after this initial period your card on file will be charged at a rate of £6.99 per month for each following month. You can log into your account on the Aktiia website to cancel this at any time in order to stop service for subsequent months.

Please contact orders@aktiia.com

If you have purchased Aktiia and chose the monthly subscription payment option you will continue to be charged a monthly fee until your commitment has been fully satisfied. If you have cancelled, it will not auto-renew.

Once your service is in the cancelled state, you will not be able to collect, upload or analyse any of your blood pressure data.

 

No, subscription contracts are not transferable.

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