Related Manuals for Aktiia Bracelet G1
Summary of Contents for Aktiia Bracelet G1
- Page 1 Bracelet G1 EN – User Manual FR – Manuel d’utilisation DE – Bedienungsanleitung IT – Manuale d’uso ENGLISH...
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Page 2: Table Of Contents
Safety symbols definitions Package contents Operating requirements Authorized 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 Battery handling and power supply... -
Page 3: Introduction
Introduction The Aktiia Bracelet G1 is the smart way to track your Blood Pressure over days and nights without any effort. The Aktiia Bracelet G1 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 85 y.o. Intended population The Aktiia Bracelet G1 is intended to be used on and by adult population, aged between 21 and 85 years old. There are no restrictions related to the user’s sex and ethnicity. -
Page 5: Intended Clinical Benefits
Aktiia’s algorithms estimate your blood pressure through advanced processing of the optical data. The 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. -
Page 6: Important Safety Information
Important warning information: A risk of swallowing and suffocation has been identified as residual risk: The pod on your Aktiia bracelet is small enough to be swallowed by a young child. To prevent risk of suffocation, never leave your Aktiia bracelet unattended! No modification of the equipment is allowed. -
Page 7: Package Contents
Package contents Make sure to remove all components from the packaging and inspect for damage. If the Aktiia packaging or any other components are damaged, do not use and contact Aktiia's Customer Service. Your Aktiia bracelet is supplied in a box containing the following items :... -
Page 8: Operating Requirements
Operating requirements To use the Aktiia bracelet you need to download the free Aktiia mobile application (Aktiia app) from the Apple App Store or Google Play. Creation of a user account via the Aktiia app is required to make use of the Aktiia bracelet. -
Page 9: Set Up And Initialization Procedures
5. Pair your Aktiia cuff with your mobile device. Unplug the Aktiia cuff from the charging cable and power ON using the toggle switch. When a blue light begins to blink, follow the cuff pairing instructions in the Aktiia app. - Page 10 7. Fit your Aktiia cuff on the opposite arm. Follow the on-screen instructions, noting the Aktiia cuff must be placed on the opposite arm as the Aktiia bracelet, i.e., if you wear the Aktiia bracelet on your RIGHT wrist, place the Aktiia cuff over your LEFT arm and vice versa.
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Page 11: Correct Aktiia Bracelet Positioning
Please note that if the cuff is too loose, the measurement will not be accurate. 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
2. Place your hand palm-side down in front of you on a flat surface such as a desk or a table. 3. The middle of the Aktiia cuff should be placed at the same level as your heart. 4. Do not move or tense your arm muscles during measurement. -
Page 13: Accessing Your Data
Your Aktiia bracelet automatically tracks your blood pressure. Measurements are triggered every hour, during the day and at night. We use a secured cloud server to store your data, not your Aktiia bracelet or your phone. Therefore, visualizing your data in the Aktiia app requires a working internet connection to synchronize with the Aktiia secure cloud server. - Page 14 Visualizing your Blood Pressure data • Use the Aktiia app to see your blood pressure data, every vertical line represents the average 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.
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Page 15: How To Evaluate Your Blood Pressure
How to evaluate your Blood Pressure The Aktiia app and devices are not intended to be diagnostic devices. Self-diagnosis of measurement results and self-treatment are potentially dangerous. You should always consult your doctor for relevant interpretation of blood pressure results. - Page 16 Europe The European Society of Hypertension (ESH) has created the following guide for classifying blood pressure values. BLOOD PRESSURE COLOR SYSTOLIC BP mmHg DIASTOLIC BP mmHg CATEGORY INDICATOR OPTIMAL LESS THAN 120 LESS THAN 80 Dark green NORMAL 120-129 AND/ OR 80-84 Light green ELEVATED...
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Page 17: Battery Handling And Power Supply
2. Connect the USB A connector (the larger side) of the USB cable to a power source. 3. Place the Aktiia bracelet on the charging station as shown below. The red light on the bottom part of the charger will start glowing. -
Page 18: Unpair Your Device
4. Press unpair Note : Unpairing is needed if the Aktiia bracelet and/or the Aktiia cuff are to be linked with a new user account. Note : Unpairing is not needed if a new mobile device is used to download the same user account's Aktiia data. -
Page 19: Troubleshooting
Troubleshooting The 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 Aktiia bracelet. - 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.
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Page 21: Care And Maintenance
3 years. Do not attempt to disassemble Aktiia Bracelet G1 as this will result in permanent damages and will void your warranty. If you encounter troubles with your Aktiia Bracelet G1 battery, please contact Aktiia customer support. -
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 / min... - Page 23 -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...
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Page 24: Emc And Rf Statements
CAUTIONS : Aktiia Bracelet G1 should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, it should be observed 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 The Aktiia Bracelet G1 is intended for use in the electromagnetic environment specified below. The user of the Aktiia Bracelet G1 should ensure that it is used in such an environment. The Aktiia Bracelet G1 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/ m 385 MHz 385 MHz communications equipment...
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Page 28: Compliance
Compliance This device complies with the following regulations and normative documents / standards: 2017 / 745 (EU) Regulation of the European Parliament and of the Council of 5 April 2017 on medical devices, repealing Council Directives 93 / 42 / EEC 2014 / 53 (EU) Directive of the European Parliament and of the Council of 16 April 2014 EN ISO 10993-5: 2009: Biological evaluation of medical devices -- Part 5 : Tests for in vitro cytotoxicity EN ISO 10993-10: 2010: Biological evaluation of medical devices. -
Page 29: Disposal
This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science, and Economic Development Canada’s license-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device. Disposal Actuation of European directives 2002 / 95 / EC, 2002 / 96 / EC and 2003 / 108 / EC, for reduction in use of dangerous substances in the electric and electronic device and for garbage disposal. -
Page 30: Network Security Recommendations
Only use mobile application authorized by Aktiia. Aktiia only makes its mobile application and subsequent updates available on official app stores. Use unique credentials (username and password) for login to your Aktiia account. Safely store your password so that no other person can access it. -
Page 31: Safety Symbols Definitions
Safety symbols definitions The signs below might be in the user manual, labeling or other component with your Aktiia Bracelet G1. Symbol Definition Symbol Definition The “CAUTION” sign in this user manual indicates a potentially hazardous situation which, The “WARNING” sign in this user manual indicates a... - Page 32 Version 3.0 – 30.06.2023 Aktiia Bracelet G1 Blood pressure monitor www.aktiia.com Medidee Services GmbH Hohnenweg 9, 78098 Triberg im Schwarzwald, Germany Emergo Australia 201 Sussex Street, Level 20, Tower II Darling Park, Sydney, NSW 2000, Australia Aktiia SA, Bassin 8a, 2000 Neuchâtel, Switzerland...
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