Aktiia Bracelet G1 User manual

Bracelet G1
EN–User Manual
ENGLISH

Content
Introduction
1
Accessing your data
14
Contact information
1
How to evaluate your blood pressure
16
Intended purpose
1
Battery handling and power supply
18
Indications for use
2
Unpair your device
19
Intended patient population
2
Troubleshooting
20
Contraindications
3
Care and maintenance
22
Important safety information
4
Warranty
23
Technological characteristics
6
Specifications
24
Package contents
7
EMC and RF Statements
26
Operating requirements
8
Electromagneticcompatibility information
28
Authorized accessories and compatible devices
8
FCC Statement
30
Setup and initialization procedures
9
Disposal
31
Correct Aktiia Bracelet positioning
11
Network Security Options
32
Correct Aktiia Cuff positioning
12
Clinical Safety Information
33
Body posture during the initialization procedure
13

Page 1
1 Introduction
Welcome to the Aktiia 24/7 Blood Pressure Monitor System! The Aktiia System is the smart way to track your Blood Pressure over days andnightswithoutany
effort. The Aktiia Bracelet isdesigned to be discreet, with no lights or alarms bothering you during your daily life. With its accuracy andease 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. Speaking of the app, make sure you download the Aktiia App from the Apple app store. The app has all the information you need to
get started with your Aktiia System.
2 Contact Information
Please read this User Manual carefully to gain a complete understanding ofthe 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.
Foranelectronic version of this user manual and for common symbols, please visit www.aktiia.com/uk/manuals/electronicsymbols
3 Intended purpose
The Aktiia Bracelet 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 an initialization process using an oscillometric blood pressure
monitor. The Aktiia Bracelet can also calculate estimated pulse rate based on the same measurement and analysis technology.

Page 2
4 Indications for use
The Aktiia 24/7 Blood Pressure Monitor System is a non-invasive monitor comprising ofan oscillometric cuff and an optical bracelet for both on-demand & continual
measurements of blood-pressure and estimated pulse rate.
The system is intended for OTC use for adult patients (ages 21-60) in an at-home environment.
5 Intended Patient Population
The Aktiia 24/7 Blood Pressure Monitor System is appropriate for users that are 21 to 60 years old, with an arm circumference of 22cm to 42cm (8 ¾ inches to 16 ½ inches)
and a wrist circumference of 14cm to 21 (5 ½ inches to 8 ¼ inches).

Page 3
6 Contraindications
Patients with the following conditions are NOT part of the intended patient population:
•Pregnant women
•Patients with the following heart conditions:
oPatients with Tachycardia and resting pulse rate greater than 120 beats per minute
oCongestive heart failure with reduced heart function
oAtrial fibrillation
oSevere valvular disease
oImplanted devices such as a pacemaker or defibrillator
•Patients with the following medical conditions:
oRenal dysfunction
oRaynaud’s disease
oActively undergoing treatment for the following endocrine disorders:
▪Diabetes
▪Pheochromocytoma
▪Hyperthyroidism
oArteriovenous fistula
oLymphoedema of the arm
oPresence ofan intravascular device
•Otherconditions:
oAny condition that might interfere with readings, such as trembling and shivering
oExfoliative skin diseases involving the wrist, such as eczema orpsoriasis
oArm amputation(s)

Page 4
7 Important safety information
Please read the important safety information inthis user manual before using the device. Any serious incidentoccurring inrelation to the Aktiia Bracelet
should be reported to Aktiia.
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!
The Aktiia Bracelet is not intended to diagnose any medical condition. The Akttia Bracelet isa monitoring device and will not alarm you based on your blood pressure readings
or pulse rate physiological alarm conditions. Consult your physician for an appropriate analysis of your blood pressure data for diagnosis.
No modification of the equipment is allowed.
The Aktiia System does not display information that would indicate a cardiovascular event, such as a heart attack, stroke, or arrhythmia. If you believe you are having a medical
emergency, call emergency services immediately
The Aktiia System is designed for assessment and monitoring of blood pressure, and it is not intended to diagnose any medical condition. The Akttia Bracelet is a monitoring device and will
not alarm you based on your blood pressure readings or pulse rate. Consult your physician for an appropriate analysis of your blood pressure data for diagnosis and management, and do
not change medications without discussing it first with your medical professional.

Page 5
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 forthe 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 yourAktiia 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.
Use of this device adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this device and the
other equipment should be observed to verify that they are operating normally.
Wireless communication devices (including home networking devices & peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of this device. Otherwise, degradation of the performance of this product could result.
Use ofthis device with active implantable medical devices, such as cardiac pacemakers andICDs,has not been evaluated andis thereforenot recommended.

Page 6
Avoid exposure of this device to known sources of EMI (electromagnetic interference) such as magnetic resonance imaging (MRI) systems, diathermy, lithotripsy,
electrocautery, RFID (radio frequency identification), and electromagnetic security systems such as metal detectors. Note that the presence of RFID devices may
not be obvious. If such interference is suspected reorient equipment if possible to maximize distances.
The performance of the Bracelet can be affected by extremes of temperature, humidity and altitude.
Do not use the device with other medical equipment simultaneously
If, at any time, the device loses Bluetooth connectivity with the phone, the user must manually reestablish connectivity with the device through the Aktiia App
The Aktiia System is intended to be used by people who have general familiarity and experience with mobile device platforms.
8 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.
Thisproduct islicensed under patentsowned byCSEM SA, Switzerland.

Page 7
9 Package contents
Your Aktiia Bracelet issupplied in aboxcontaining the following items:
1 Aktiia Bracelet with Pod and Strap
1Chargingstation +
1 USB cable
1 User Manual
Latest version oftheAktiia Bracelet user manual can also be found online at:
https://aktiia.com/uk/manuals/

Page 8
10 Operating requirements
To use the Aktiia System, you should have general familiarity and experience using mobile device platforms.
To use theAktiia Bracelet you need to download the free Aktiia App from the Apple App store.
Creation of a user account and login are required to operate theAktiia Bracelet.
Access to the Internet is required to:
•Download the Aktiia App.
•Setupyour Aktiia user account.
•Update Aktiia Monitor’s firmware.
•Visualize your new Blood Pressure data.
•Receive insights on your Blood Pressure readings.
11 Authorized accessories and compatible devices
Your Aktiia Bracelet requires initialization and periodic re-initialization every 7 days. The Aktiia Bracelet must beused with the complementary Aktiia
Cuff. TheAktiia Cuff is an oscillometric device provided by Aktiia in a separate package.
The Aktiia mobile application requires a mobile device with iOS 11 orlater, Bluetooth 4.2 orhigher and Wi-fi or3G /4G / 5G connection.