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Summary of Contents for Aktiia G2C
- Page 1 Aktiia G2C User Manual...
- Page 2 Disposal Operating requirements Network security recommendations Safety symbols definitions Set up procedure for Aktiia Bracelet G2C Correct Aktiia bracelet G2C positioning Body posture during the Blood Pressure measurement and measurement request with Aktiia Bracelet G2C Set up procedure for camera measurement with a compatible...
- Page 3 Introduction The Aktiia G2C device is the smart way to obtain your Blood Pressure. The Aktiia G2C device is designed to be discreet and practical, with no alarms bothering you during your daily life. With its accuracy and ease of use, the Aktiia G2C device is the perfect solution to monitor your blood pressure.
- Page 4 • amputated index fingers. Intended population Aktiia G2C blood pressure monitoring system is intended for adult population, aged between 21 and 85 years old. There are no restrictions related to the user’s sex and ethnicity. 3 – EN...
- Page 5 Aktiia mobile application to a secured cloud server on which Aktiia’s algorithms compute your blood pressure, through advanced processing of the optical data. For the Aktiia Bracelet G2C, the Aktiia’s algorithms detect if the user is moving before proceeding with a PPG measurement and will provide blood pressure measurement only when the user is still and wearing the device correctly.
- Page 6 Important warning information: A risk of swallowing and suffocation has been identified as residual risk: The pod on your Aktiia bracelet G2C 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 Make sure to remove all components from the packaging and inspect for damage. If the Aktiia packaging or any other components are damaged or open upon reception, do not use and contact Aktiia's Customer Service through our Help Center / FAQ (Frequently Asked Questions) on our website at www.aktiia.com..
- Page 8 Operating requirements To use the Aktiia G2C device you need to download the Aktiia mobile application (Aktiia app) from the Apple App Store. Creation of a user account via the Aktiia app is required to make use of the Aktiia G2C device.
- Page 9 3. Create a user account on the Aktiia app. Open the Aktiia app on your mobile device and follow the instructions to register and set up your personal account. You will need access to your personal email in order to validate your new Aktiia account.
- Page 10 Correct Aktiia bracelet G2C positioning Fasten your Aktiia bracelet around your wrist with the sensor facing toward the skin on top of the wrist. The clasp is on the underside of the wrist. The sensor on the pod should be placed in direct contact with the skin. Tighten the bracelet to be snug but comfortable to ensure that the bracelet does not move around while using your hands.
- Page 11 Body posture during the Blood Pressure measurement and measurement request with Aktiia Bracelet G2C Please sit down before starting the Blood Pressure measurement. Note : Blood Pressure measurements can be affected by your physiological and emotional condition. 1. With your feet flat on the ground and your back straight, sit up straight. Avoid crossing your legs.
- Page 12 You will need access to your personal email in order to validate your new Aktiia account. Please make sure you enter accurate personal data (biological sex, date of birth, height and weight) when requested by the Aktiia App. This information will be used by the product to generate your blood pressure and heart rate measurements.
- Page 13 Correct index finger positioning for camera measurement with a compatible smartphone Hold your phone firmly with one hand. Make sure your index finger is fully covering the rear camera. You will see the active lens after the instructions. Rest your hand, along with the phone, on a stable surface to keep it steady while measuring. Once ready, lightly press your finger against the camera lens to make sure it's fully covered.
- Page 14 4. Do not move or tense your arm muscles during measurement. 5. Relax, and do not move or talk. 6. Perform measurement requesting it through the Aktiia application and follow instructions of the Aktiia application during the 3 cycles of measurements.
- Page 15 We use a secured cloud server to store your data, not your Aktiia bracelet or your phone. Therefore, getting and visualizing your data in the Aktiia app requires a working internet connection to synchronize with the Aktiia secure cloud server.
- Page 16 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.
- Page 17 How to evaluate your Blood Pressure The Aktiia app and device are not intended to be 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.
- Page 18 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...
- Page 19 1. Connect the USB connector of the charging station to a power source. 2. Place the Aktiia bracelet on the charging station as shown below. The red light on the bottom part of the charger will start glowing. 3. A steady red light indicates that the device is fully charged.
- Page 20 Note : Unpairing is needed if the Aktiia bracelet is 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. 19– EN...
- Page 21 Verify that the charging station is well connected to a power supply through the USB cable provided. I don’t see a red light when Try replacing the Aktiia bracelet by turning it through 180°. The charging pins on the pod should be aligned with charging my Aktiia bracelet the ones on the charging station.
- Page 22 If the problem persists, contact Aktiia Customer Service. I cannot pair my Aktiia bracelet with Verify that your Aktiia bracelet is correctly placed on the charger and that a red light is visible at the bottom of the charging the Aktiia app station.
- Page 23 Do not attempt to disassemble Aktiia Bracelet G2C as this will result in permanent damages and will void your warranty. To mitigate the risk of skin irritation, it is advisable to maintain regular cleanliness of your Aktiia Bracelet G2C. Simply use a damp cloth to gently clean your Aktiia Bracelet G2C, followed by drying with a soft cloth.
- Page 24 Information about water resistance levels The Aktiia Bracelet G2C of your Aktiia G2C device can be worn when dishwashing, splashing, showering or swimming. However, it cannot be used for diving or snorkeling. Please carefully read the cautionary statements below before wearing the Aktiia Bracelet G2C: •...
- Page 25 Measurement accuracy (Blood Pressure) ± 5 mmHg 23 – EN...
- Page 26 Compatible Smartphone for camera iPhone 12, 13, 14, 15 and 16 series. measurement The Aktiia Bracelet G2C battery can maintain the performance characteristics for a maximum of 300 charge cycles, which corresponds to an expected service life of 3 years. 24 – EN...
- Page 27 The warranty extends only to the end user. We will, at our option, repair or replace without charge the Aktiia Bracelet G2C covered by the warranty. Repair or replacement is our only responsibility and your only remedy under the warranty.
- Page 28 CAUTIONS : Aktiia Bracelet G2C 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 29 The user of the Aktiia Bracelet G2C should ensure that it is used in such an environment. The Aktiia Bracelet G2C 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 30 Guidance and manufacturer’s declaration - electromagnetic immunity The Aktiia Bracelet G2C is intended for use in the electromagnetic environment specified below. The user of the Aktiia Bracelet G2C should ensure that it is used in such an environment. The Aktiia Bracelet G2C 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 31 Guidance and manufacturer’s declaration - electromagnetic immunity Immunity test 60601-1-2 test levels Compliance 3 V 0,15 MHz – 80 MHz 3 V 0,15 MHz – 80 MHz Immunity to conducted disturbances, induced by 6 V in ISM and radio-amateur band between 0,15 MHz 6 V in ISM and radio-amateur band between 0,15 MHz and 80 radio-frequency and 80 MHz...
- Page 32 Electromagnetic disturbances – Requirements and tests IEC 60601-1-6:2010 / A1:2013/A2:2020: Medical electrical equipment - Part 1-6 : General requirements for basic safety and essential performance – Collateral standard: Usability IEC 60601-1-11:2015/A1:2020: Medical electrical equipment – Part 1-11 : General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN IEC 62471:2008: Photobiological safety of lamps and lamp systems ETSI EN 301489-1 v2.2.3: ElectroMagnetic Compatibility (EMC) standard for radio equipment and services;...
- Page 33 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. In accordance with the IEC 60601-1 standard, this medical device does not have essential performance.
- Page 34 30 – EN 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. The 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 .
- Page 35 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 36 Safety symbols definitions The signs below might be in the user manual, labeling or other component with your Aktiia G2C device. Symbol Definition Symbol Definition The “WARNING” sign in this user manual indicates a The “CAUTION” sign in this user manual indicates a potentially hazardous situation which,...
- Page 37 Version 8.0 – 2024.11.15 Aktiia G2CBlood pressure monitor www.aktiia.com Veranex Germany GmbH Landsberger Str. 302, D-80687 Munich, 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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