Table of Contents
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This confidential document
Objectives
This document is the User Manual associated to aktiia.bracelet. It will be provided electronically
to the end-user through Aktiia website.
Revision History
Revision
Revision Date
1
2
13.09.2019
Approval
Role
Name
Author
Elisa Olivero
Reviewer
Nadège Siutryk
Approval
Valentin Chapuis
Printed copies are uncontrolled - Check you are using the latest version
P01_0020 - USER MANUAL
P01_0020 - User Manual
N/A
Initial version
Edited as a revision controlled document (prior release v1 was not yet
under revision control)
Inclusion of requirements from IEC 60601-1-2 for Emission and Immunity
Title
Product Manager
Project Manager
Quality Manager
Summary of Changes
Date/Signature
13.09.2019 - PO Valentin Chapuis
13.09.2019
13.09.2019
Version: 2
Page 1 of 14
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Summary of Contents for Aktiia Bracelet
- Page 1 Version: 2 This confidential document is the property of Aktiia P01_0020 - User Manual Objectives This document is the User Manual associated to aktiia.bracelet. It will be provided electronically to the end-user through Aktiia website. Revision History Revision Revision Date...
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Page 2: Is The Property Of Aktiia
Non-invasive optical blood pressure monitor 0123 Supplied with a charging station and a USB cable www.aktiia.com Aktiia SA, Pierre-à-Mazel 39, 2000 Neuchâtel, Switzerland www.aktiia.com/ifu Page 2 of 14 Printed copies are uncontrolled - Check you are using the latest version... -
Page 3: Table Of Contents
Contraindications ................................4 Cautions .................................... 4 Package contents ................................5 Setup and first initialization procedures ........................5 Correct AKTIIA bracelet positioning ..........................6 Correct AKTIIA Cuff positioning ............................. 6 Body Posture during the Initialization Procedure ...................... 7 Accessing your data ................................ 7 How to evaluate your Blood Pressure ........................ -
Page 4: Intended Use And Technological Characteristic
Introduction AKTIIA bracelet is the smart way to track your systolic and diastolic Blood Pressure and Heart Rate over days and nights without any effort. AKTIIA bracelet is designed to be discreet, with no lights or alarms bothering you during your daily tasks. -
Page 5: Package Contents
Version: 2 This confidential document is the property of Aktiia Your AKTTIA Bracelet Pod is small enough to be swallowed by a young child. To prevent risk of suffo- cation, never leave your Pod unattended ! 4. Package contents Your AKTTIA Bracelet is supplied in a box containing the following items :... -
Page 6: Correct Aktiia Bracelet Positioning
6. Correct AKTIIA bracelet positioning Wear your Aktiia Bracelet on the elbow side of your wrist bone. The sensing side of the pod should be placed in direct contact with the skin, on the top part of the wrist. The Bracelet should be snug but comfortable. -
Page 7: Body Posture During The Initialization Procedure
Your AKTIIA Bracelet automatically tracks your blood pressure. Measurements are triggered every hour, day and night. To ensure optimal data security, your data are not stored on AKTIIA bracelet but on a secured cloud server. Visualizing your data in AKTIIA App therefore requires a synchronization process with our server. -
Page 8: How To Evaluate Your Blood Pressure
Figure 3 10. 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 interpre- tation of blood pressure results. -
Page 9: Europe
If your mobile device Bluetooth is activated but your AKTIIA Bracelet still does not not connect to my mo- connect, place your AKTIIA Bracelet on the charging station to force a reset (you will bile device. not lose your personal data or account information). -
Page 10: Care And Maintenance
If you encounter troubles with your AKTIIA Bracelet battery, please contact AKTIIA customer support. 13. Warranty Your AKTIIA Bracelet is warranted to be free from defects in materials and workmanship within one year from the date of purchase when used in accordance with the provided instructions. The warranty extends only to the end user. -
Page 11: Emc And Rf Statements
AKTIIA bracelet uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. -
Page 12: Ce Compliance
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. -
Page 13: Fcc Statement
Version: 2 This confidential document is the property of Aktiia EN ISO 10993-10: 2010: Biological evaluation of medical devices. Tests for irritation and skin sensitization EN IEC 60601-1:2006/A1:2013: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance EN IEC 60601-1-2:2015: Medical electrical equipment –... -
Page 14: Disposal
This product complies with RoHS Directive 2011/65/EU and Amendment (EU) 2015/863. 20. Safety Information The signs below might be in the user manual, labeling or other component with your AKTIIA Bracelet. Symbol for “CAUTION”, Indicates the Symbol for “THE INSTRUCTION need for the user to consult the FOR USE MUST BE READ”, with ref-...
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