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 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.
Page 9
**Quality of Service of Aktiia Bracelet G1: In regard to Quality of Service, the Aktiia Bracelet connects to the app using Bluetooth Low Energy (BLE). The BLE radio of the
bracelet is always on and discoverable. Once the device has been paired to the app, no specific action is required for an authenticated user to connect to it. The Aktiia
System is primarily intended for retrospective review of blood pressure and pulse rate data, there are no risks associated with data latency and throughput. The device is
not being used as diagnostic tool and there are no alarms.
Page 10
12 Set up and initialization procedures
1. Charge Bracelet before First Use.
To charge the Bracelet:
•Connect the charging station to a USB port using the charging cable provided
•Remove the thin plastic protective film that is attached to the bottom of the pod of the Bracelet before charging
•PlacetheAktiia Bracelet, with the sensor on the bottom,onto the chargingstation.
•Ared lightatthe bottom ofthe charger willbegin glowing to indicate that the bracelet has been placed correctly on thecharging station.
•When charging is completed, the red light is steady.
2. Download theAktiia App.
Scan the QR code on this page orgo to the Apple App Store, then download and install theAktiia App.
3. Create a user account on theAktiia App.
Open the Aktiia App onyour mobile device andfollow theinstructions to register andsetupyour personal account.
4. Pair your Aktiia Bracelet with your mobile device.
PlacetheAktiia Bracelet on the charging station and enable Bluetooth connection on your mobile device. Wait until pairing is confirmed bytheAktiia App.
5. Pair your Aktiia Cuff with your mobile device.
Switch ON the Aktiia Cuff byturning on the toggle button. Ablue light should start blinking. Wait until pairing is confirmed bytheAktiia
App andthe light indicator isa steadyblue.For further information ontheAktiia Cuff operation, please refer to the user manual.
Page 11
6. Fit yourAktiia Bracelet on your wrist.
For optimal measurement by the Aktiia Bracelet, please carefully read the
instructions inthe “Correct Aktiia Bracelet positioning” section of this user manual.
7. Fit your Aktiia Cuff on the opposite arm.
The Aktiia Cuff must be placed on the opposite arm than the one wearing the Bracelet (i.e ifyou wear your Aktiia Bracelet
on your RIGHT wrist, place the Cuff over your LEFT arm and vice versa).
The accuracy of blood pressure measurement done by the 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 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” of this user manual.
Page 12
Congratulations! Your Aktiia Bracelet is now initialized and ready to track your blood pressure!
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.
You need to complete an initialization procedure at least once every 7days, when prompted by the mobile application. The notification to reinitializewill appear beginning on
Day 5. If you do not reinitialize by Day 7, you will no longer see new data on your App. Data obtained outside the period may be inaccurate.
13 Correct Aktiia Bracelet positioning
Fasten your Aktiia Bracelet around your wrist with the sensor (Aktiia Pod) facing toward or placed
against the skin on top of your wrist. The clasp will be on the underside of the wrist. The bracelet
should be about 1 inch from your most prominent wrist bone. This ensures that the Bracelet does not
move around asmuch whenyou are using your hands. The Bracelet should be snug butcomfortable.
Page 13
14 Correct Aktiia Cuff positioning
The Aktiia Cuff must be placed on the opposite arm with respectto the one wearing the Bracelet (i.e if you wear your 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 flow constriction.
2. Place your bare arm through the Cuff andposition the Cuff 1"(2-3 cm) above your elbowjoint. The middle of
the Cuff should be placed as the same level as your heart.
3. Tighten the Cuff around your arm so that itfits closely but you can still insert two fingers between your armand
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 flat surface and the
Aktiia Cuff isat the same heightasyour heart.Your Aktiia Cuffmonitor is positioned onthe innerside ofyour
arm, over the artery and the logo is towards your elbow joint.
Please check the instructions for use provided with the
Aktiia Cuff initialization device
Page 14
15 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, keep your legs uncrossed, and yourfeetflat onthe floor.
2. Place both your handspalm-side down in frontof you on a flat surface such asa desk or a
table up to and including your elbow.
3. Donotmove or tense your arm muscles during measurement.
4. Relax, anddo not talk.
Page 15
16 Accessingyour data
Your Aktiia Bracelet automatically tracks your blood pressure, periodically measuring
throughout the day and night. To ensure optimal data security, your data is stored on a
secured cloud server, andnotthe Aktiia Bracelet or on your phone.Visualizingyour data in
the Aktiia App therefore requires internet connection to synchronize with Aktiia’s secure
server.
Syncing your data
•Make sure Bluetooth and Internet connection on your mobile device are enabled.
•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.
Page 16
Visualizing your Blood Pressure data
•Pressthe Home buttonon the Aktiia App to see your blood pressure data in a chart format.
•The top is the systolic (SYS) value and the bottom the diastolic (DIA) value. Tap on the line to
read the numeric values, hold, andmove your finger on the screen to navigate through the values.
•In the Aktiia App you will be shown metrics such as the average Blood Pressure values for the day.
•You are also able to swipe left andrightto navigate through your historical data,in day, week, and
month view.
Page 17
17 How to evaluate your blood pressure
The Aktiia Bracelet 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 physiological alarm conditions. Consult your physician for an appropriate analysis of your blood pressure data for diagnosis.
The following classifications are based on measurements taken on a seated person after few minutes of rest.
It is important to note that Blood Pressure readings in normal life conditions might be higher.
Thesechartsare not intended to provide a basis for anytype ofdiagnosisor emergencyassessment;
these charts only depict different classifications of blood pressure.
Consult your physician for aninterpretation and diagnosis based onyour personal blood pressure results. Ifyou feel that your readings are abnormal, contact your
physician.
Page 18
The American Heart Association (AHA) hascreated the following guide for classifying blood pressure values.
BLOOD PRESSURE
CATEGORY
SYSTOLIC BP
mm Hg (upper number)
AND/OR
DIASTOLIC BP
mmHg (lower number)
COLOR
INDICATOR
NORMAL
LESS THAN 120
AND
LESSTHAN 80
Green
ELEVATED
120-129
AND
LESS THAN 80
Yellow
HIGHBLOOD PRESSURE (HYPERTENSION)
STAGEI
130-139
OR
80-89
Orange
HIGH BLOOD PRESSURE STAGE
(HYPERTENSION) 2
140 OR HIGHER
OR
90 OR HIGHER
Light Red
HYPERTENSIVECRISIS (consult your doctor
immediately)
HIGHER THAN 180
AND/OR
HIGHER THAN 120
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.
Other manuals for Bracelet G1
2
Table of contents
Other Aktiia Blood Pressure Monitor manuals
