Aktiia Bracelet G1 User Manual
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Aktiia Bracelet G1 User Manual

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Bracelet G1
EN–User Manual
ENGLISH

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Summary of Contents for Aktiia Bracelet G1

  • Page 1 Bracelet G1 EN–User Manual ENGLISH...

  • Page 2: Table Of Contents

    EMC and RF Statements Operating requirements Electromagnetic compatibility information Authorized accessories and compatible devices FCC Statement Setup and initialization procedures Disposal Correct Aktiia Bracelet positioning Network Security Options Correct Aktiia Cuff positioning Clinical Safety Information Body posture during the initialization procedure...

  • Page 3: 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 and nights without any effort. The 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

    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 5: Contraindications

    Contraindications Patients with the following conditions are NOT part of the intended patient population: • Pregnant women • Patients with the following heart conditions: Patients with Tachycardia and resting pulse rate greater than 120 beats per minute Congestive heart failure with reduced heart function Atrial fibrillation Severe valvular disease Implanted devices such as a pacemaker or defibrillator...

  • Page 6: Important Safety Information

    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 7 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.

  • Page 8: Technological Characteristics

    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 t he Aktiia App The Aktiia System is intended to be used by people who have general familiarity and experience with mobile device platforms.

  • Page 9: 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 1 User Manual Latest version of the Aktiia Bracelet user manual can also be found online at: https://aktiia.com/uk/manuals/ Page 7...

  • Page 10: Operating Requirements

    Cuff. The Aktiia Cuff is an oscillometric device provided by Aktiia in a separate package. The Aktiia mobile application requires a mobile device with iOS 11 or later, Bluetooth 4.2 or higher and Wi-fi or 3G / 4G / 5G connection.
  • Page 11 **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.

  • Page 12: Setup And Initialization Procedures

    4. Pair your Aktiia Bracelet with your mobile device. Place the Aktiia Bracelet on the charging station and enable Bluetooth connection on your mobile device. Wait until pairing is confirmed by the Aktiia App. 5. Pair your Aktiia Cuff with your mobile device.
  • Page 13 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 if you wear your Aktiia Bracelet on your RIGHT wrist, place the Cuff over your LEFT arm and vice versa).

  • Page 14: Correct Aktiia Bracelet Positioning

    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 is a monitoring device and will not alarm you based on your blood pressure readings or pulse rate physiological alarm conditions.

  • Page 15: Correct Aktiia Cuff Positioning

    Correct Aktiia Cuff positioning The Aktiia Cuff must be placed on the opposite arm with respect to 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).

  • Page 16: 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, keep your legs uncrossed, and your feet flat on the floor. 2.

  • Page 17: Accessing Your Data

    To ensure optimal data security, your data is stored on a secured cloud server, and not the Aktiia Bracelet or on your phone. Visualizing your data in the Aktiia App therefore requires internet connection to synchronize with Aktiia’s secure server.
  • Page 18 • 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 and right to navigate through your historical data, in day, week, and month view.

  • Page 19: How To Evaluate Your Blood Pressure

    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.
  • Page 20 The American Heart Association (AHA) has created the following guide for classifying blood pressure values. BLOOD PRESSURE SYSTOLIC BP DIASTOLIC BP COLOR AND/OR CATEGORY mm Hg (upper number) mm Hg (lower number) INDICATOR NORMAL LESS THAN 120 LESS THAN 80 Green ELEVATED 120-129...

  • Page 21: 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 22: Unpair Your Device

    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...

  • Page 23: 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 24 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 25: Care And Maintenance

    3 years. Do not attempt to disassemble The Aktiia Bracelet as this will result in permanent damages and will void your warranty. If you encounter troubles with your Aktiia Bracelet battery, please contact Aktiia customer support.

  • Page 26: Warranty

    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 27: Specifications

    Specifications Product description Blood pressure monitor Model Aktiia Bracelet G1 Measurement method Photoplethysmography (PPG) Sensor to measure PPG Green light (wavelength 526nm); silicon receiver diode Measurement accuracy (Blood Pressure) ± 5mmHg Measurement accuracy (Pulse Rate) ± 5 pulse/min Measurement range...
  • Page 28 -20°C to +60°C Storage and transportation conditions 700hPa to 1060hPa10% 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). Bracelet essential performance: Safety...
  • Page 29 The Aktiia System is suitable for use in all establishments, including domestic establishments and those directlyconnected to the public low voltage power supply network that supplies buildings used for domestic purposes. The Aktiia System uses RF energy only for its internal function. Therefore, its RF emissions are very lowand are not likely to cause any interference in nearby electronic equipment.
  • Page 30 If such interference is suspected reorient equipment if possible, to maximize distances. 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. Page 28...
  • Page 31 Guidance and manufacture’s declaration - electromagnetic emissions The Aktiia System 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. The Aktiia System 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 32 Guidance and manufacturer’s declaration - electromagnetic immunity The Aktiia System is intended for use in the electromagnetic environment specified below. The user of the Aktiia System should ensure that it is used in such an environment. The Aktiia System 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 33 Power frequency magnetic field IEC 61000-4-8 30 A/ m 30 A/ m 50 Hz 50 Hz Olivier Essential Performance: Performance as required by IEC 60601-1-2 and IEC 80601-2-30 clause 202.8.1.101 for basic safety, the bracelet connects with the app. For the EMC the following were monitored during testing: Normal Mode: If the EUT does not sync measured data after performing a test, and/or if the measurements are unsatisfactory in accordance to IEC 80601-2-30 clause 202.8.1.101 as below then it is considered a failure.
  • Page 34 After the tests, the following rules need to be met: NRF2_Num_Precise_Rec/ NRF2_Num_meas_Rec > 0.96. NRF2_acceptance is calculated. Aktiia SA monitored the accuracy of parameters from the raw data provided by Intertek. These parameters were monitored, during and after exposure to non-transient phenomena; and after exposure to transient phenomena.
  • Page 35 EMC Test Plan & Summary The Aktiia System is intended for use in the electromagnetic environment specified below from the EMC testing.report The user of Aktiia Bracelet should ensure that it is used in such an environment. The Aktiia System 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 36 Charging Mode at 120 Vac 60 Hz Normal ANSI C63.4 Radiated Emission Mode on Battery Mode ANSI C63.4 Conducted Emission AC Power Charging Mode at 120V 60Hz EN/IEC 61000-4-2 Enclosure Electrostatic Discharge, Charging Mode at 120 Vac 60 Hz Normal ±...
  • Page 37 EN/IEC 61000-4-4 Fast Transient/Burst AC Power Charging Mode at 120 Vac 60 Hz ± 2 kV, 5/50 nsec pulse, 100 kHz repetition freq. Fast Transient/Burst DC Power Not Applicable ± 2 kV, 5/50 nsec pulse, 100 kHz repetition freq. Fast Transient/Burst Input/ Output Not Applicable (Capacitive clamp)
  • Page 38 IEC 60601-1-2 (Edition 4.0): 2014+AMD1:2020, FCC Part 15 Subpart B, ISED ICES-003 Proposed Tests for Home Healthcare Environment Basic Standard Test Specifications Applicable Ports Pass/Fail Comments Continuous Conducted RF, 80% AM (1 EN/IEC 61000-4-6 AC Power kHz) Charging Mode at 3 Vrms, 0.15-80 MHz 120 Vac 60 Hz 6 Vrms in ISM and amateur radio Bands...
  • Page 39 Continuous Conducted RF, Input/ Output Lines 80% AM (1 kHz) Not Applicable 3 Vrms, 0.15-80 MHz 6 Vrms in ISM and amateur radio Bands within 150kHz – 80MHz Cables longer than 3 m Continuous Conducted RF, PATIENT 80% AM (1 kHz) coupling PORT Not Applicable 3 Vrms, 0.15-80 MHz...
  • Page 40 Proximity Magnetic Fields 8A/m, CW, 30kHz; Charging Mode at 120 65A/m (rms), PM at 2.1 kHz, 50% duty Vac 60 Hz Normal EN/IEC 61000-4-39 Enclosure cycle, 134.2kHz; Mode on Battery Mode 7.5A/m (rms), PM at 50 kHz, 50% duty cycle, 13.56MHz EN/IEC 61000-4-11 Voltage Dips 30% reduction, 25/30 periods AC Power...
  • Page 41 Voltage Dips > 95% AC Power reduction, 1 period At 0° Voltage Interruptions > 95% AC Power Not Applicable reduction, 250/300 periods Page 39...
  • Page 42 EN 61000-3-2 AC Power Not Applicable 5 Emissions: Harmonics Disturbances EN 61000-3-3 AC Power Not Applicable Emissions: Voltage Fluctuation The EUT does not contain signal input/output lines longer than 3 m in length. The EUT does not contain signal ports that connect directly to the outdoors. The EUT does not contain any patient coupling ports.
  • Page 43 CISPR 11 Radiated Emission Complies CISPR 11 Conducted Emission AC Power Complies EN/IEC 61000-4-2 Enclosure Electrostatic Discharge, Complies ± 8 kV contact discharge Electrostatic Discharge, Enclosure ± 15 kV air discharge Electrostatic Discharge, PATIENT Not Applicable ± 8 kV contact discharge coupling PORT Electrostatic Discharge, PATIENT...
  • Page 44 EN/IEC 61000-4-4 Fast Transient/Burst AC Power Complies ± 2 kV, 5/50 nsec pulse, 100 kHz repetition freq. Fast Transient/Burst DC Power Not Applicable ± 2 kV, 5/50 nsec pulse, 100 kHz repetition freq. Fast Transient/Burst Input/ Output Lines Not Applicable (Capacitive clamp) ±...
  • Page 45 IEC 60601-1-2 (Edition 4.0): 2014+AMD1:2020 Test Summary for Home Healthcare Environment Basic Standard Test Specifications Applicable Ports Pass/F Comm ents Continuous Conducted RF, 80% AM (1 EN/IEC 61000-4-6 AC Power kHz) Compli 3 Vrms, 0.15-80 MHz 6 Vrms in ISM and amateur radio Bands within 150kHz –...
  • Page 46 Continuous Conducted RF, Input/ Output Lines 80% AM (1 kHz) Applica ble 1 3 Vrms, 0.15-80 MHz 6 Vrms in ISM and amateur radio Bands within 150kHz – 80MHz Cables longer than 3 m Continuous Conducted RF, PATIENT coupling 80% AM (1 kHz) PORT Applica 3 Vrms, 0.15-80 MHz...
  • Page 47 Radiated Fields in close proximity 8A/m, CW, 30kHz; 65A/m (rms), PM at 2.1 kHz, 50% duty cycle, 134.2kHz; EN/IEC 61000-4-39 Enclosure Compli es 6 7.5A/m (rms), PM at 50 kHz, 50% duty cycle, 13.56MHz Voltage Dips 30% reduction, 25/30 periods EN/IEC 61000-4-11 AC Power At 0°...
  • Page 48 Voltage Dips > 95% reduction, AC Power 1 period At 0° Voltage Interruptions > 95% AC Power reduction, 250/300 periods Applica Page 46...
  • Page 49 EN 61000-3-2 AC Power Emissions: Harmonics Disturbances Applica ble 5 EN 61000-3-3 Emissions: Voltage Fluctuation AC Power Applica The EUT does not contain signal input/output lines longer than 3 m in length. The EUT does not contain signal ports that connect directly to the outdoors. The EUT does not contain any patient coupling ports.
  • Page 50 Page 48...

  • Page 51: Fcc Statement

    —Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. —Consult the dealer or an experienced radio/TV technician for help. The FCC-ID is located in the settings menu of the Aktiia App. Page 49...

  • Page 52: Disposal

    Disposal This symbol applied on the device or its packaging means that at the end of its useful life the product must not be disposed of with domestic waste. At the end of the device’s useful life, the user must deliver it to the able collecting centers for electric and electronic garbage or give back to the retailer when purchasing a new device.
  • Page 53 (e.g. Apple 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 54: Clinical Safety Information

    Performance Because the Aktiia system is not intended to be used only for a single measurement, but to repeatedly measure the BP of a user over the long-term, it is also important that the device provides a reliable representation of BP over time. The results of a subject-level analysis that included all the data collected over the one-week study period found that the device error for systolic BP is within 10 mm Hg for 85% of users and for diastolic BP within 10 mm Hg for 75% of users.
  • Page 55 Aktiia Bracelet G1 Blood pressure monitor Aktiia SA, Bassin 8a, 2000 Neuchâtel, Switzerland Website : www.aktiia.com Customer Service: support@aktiia.com User Manual & Symbols Glossary: www.aktiia.com/uk/manuals/electronicsymbols Version 1 – 11/10/2022...

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