Aktiia Bracelet G1 User Manual
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Bracelet G1
EN –  U ser Manual

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Summary of Contents for Aktiia Bracelet G1

  • Page 1 Bracelet G1 EN –  U ser Manual...
  • Page 2: Table Of Contents

    Important safety information Package contents Operating requirements Authorized accessories and compatible devices Set up and initialization procedures Correct Aktiia Bracelet positioning Correct Aktiia Cuff positioning Body posture during the initialization procedure Accessing your data How to evaluate your Blood Pressure...
  • Page 3: 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 .
  • Page 4: Indications For Use

    21 y.o. and above 65 y.o. Clinical benefits 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.
  • Page 5: Technological Characteristics

    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  /   o r patient is established.
  • Page 6 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.
  • Page 7: Package Contents

    Package contents Your Aktiia Bracelet is supplied in a box containing the following items  : 1 Aktiia Bracelet with Pod and Strap 1 Charging station + 1 USB cable Latest version of Aktiia Bracelet user manual can also be found online at  : 1 User Manual www.aktiia.com/ifu 6 – EN...
  • Page 8: Operating Requirements

    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  : •...
  • Page 9: Set Up And Initialization Procedures

    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.
  • Page 10 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.
  • Page 11: Correct Aktiia Bracelet Positioning

    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 is at the same height as your heart.
  • Page 12: Body Posture During The Initialization Procedure

    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 flat on the floor. 2.
  • Page 13: 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.
  • Page 14 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.
  • Page 15: How To Evaluate Your Blood Pressure

    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 classifications are based on measurements taken on a seated person after few minutes of rest.
  • Page 16 Europe The European Society of Hypertension (ESH) has created the following guide for classifying blood pressure values. BLOOD PRESSURE SYSTOLIC BP DIASTOLIC BP COLOR CATEGORY mmHg mmHg INDICATOR OPTIMAL LESS THAN 120 LESS THAN 80 Dark Green AND  /   O R NORMAL 120-129 80-84 Light Green...
  • Page 17: Battery Handling And Power Supply

    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 fixed battery and can only be changed by an authorized Aktiia Service agent.
  • Page 18: Unpair Your Device

    4. Press unpair Note  : Unpairing is needed if Aktiia Bracelet and  /   o r 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...
  • Page 19: Troubleshooting

    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.
  • Page 20 If your mobile device Bluetooth is activated but your Aktiia Bracelet still does not connect, my mobile device 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.
  • Page 21: Care And Maintenance

    Issues related by strap’s wearing are not covered by the warranty. The warranty extends only to the end user. We will, at our option, repair or replace without charge Aktiia Bracelet covered by the warranty.
  • Page 22: Specifications

    Specifications Product description Blood pressure monitor Model Aktiia Bracelet G1 Measurement method Photoplethysmography (PPG) Sensor to measure PPG Green light (wave-length 526nm); silicon receiver diode Measurement accuracy (Blood Pressure) ± 5mmHg Measurement accuracy (Heart Rate) ± 5 pulse  /   m in Measurement range 40-250 mmHg for blood pressure, 40-180 beats  /   m in for heart rate...
  • Page 23 700hPa to 1060hPa 15 % to 90 % RH -20°C to +60°C Storage and transportation conditions 700hPa to 1060hPa 10% to 95% RH Aktiia Bracelet size 14 cm to 21 cm / 5 ½ to 8 ¼ inches (circumference) Aktiia Bracelet weight approximatively 18g (0.6 ounces). 22 – EN...
  • Page 24: Emc And Rf Statements

    CAUTIONS  : Aktiia Bracelet should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, it should be observed in order to verify normal operation in the configuration in which it will be used.
  • Page 25: Electromagnetic Compatibility Information

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Aktiia Bracelet, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”...
  • Page 26 Guidance and manufacturer’s declaration - electromagnetic immunity Aktiia Bracelet is intended for use in the electromagnetic environment specified below. The user of Aktiia Bracelet should ensure that it is used in such an environment. Aktiia Bracelet is suitable for use in “Home Healthcare Environment”, i.e. all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
  • Page 27 9 V  /   m 9 V  /   m 710 MHz, 745 MHz, 710 MHz, 745 MHz, 780 MHZ, 5240 MHz, 5550 MHz, 5785 MHz 780 MHZ, 5240 MHz, 5550 MHz, 5785 MHz Proximity fields from RF wireless 27 V  /   m 27 V ...
  • Page 28: Ce Compliance

    CE compliance This device complies with the following regulations and normative documents  /   s tandards  : 2017  /   7 45 (EU) Regulation of the European Parliament and of the Council of 5 April 2017 on medical devices, repealing Council Directives 93  /   4 2  /   E EC 2014 ...
  • Page 29: Disposal

    Disposal Actuation of European directives 2002  /   9 5  /   E C, 2002  /   9 6  /   E C and 2003  /   1 08  /   E C, for reduction in use of dangerous substances in the electric and electronic device and for garbage disposal.
  • Page 30: Network Security Recommendations

    (e.g. Google App store). Use unique credentials (username and password) for login to your Aktiia account. Safely store your password so that no other person can access it. It is recommended to regularly update your password, at least once every 3 months.
  • Page 31: Safety Information

    Safety information The signs below might be in the user manual, labeling or other component with your Aktiia Bracelet. The “CAUTION” sign in this user manual indicates a potentially hazardous situation which, Symbol for “IFU are available on ww.Aktiia.com/ifu” if not avoided, could result in minor injury to the user or patient or damage to the equipment or other property.
  • Page 32 Version 16 – 03.12.2020 Aktiia Bracelet G1 Blood pressure monitor www.aktiia.com Medidee Services GmbH Hohnenweg 9, 78098 Triberg im Schwarzwald, Germany Aktiia SA, Bassin 8a, 2000 Neuchâtel, Switzerland...

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