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Summary of Contents for Aktiia Init I1
- Page 1 Init I1 EN – U ser Manual...
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Page 2: Table Of Contents
Contraindications Technological characteristics Important safety information Package content Power supply and charging Correct Aktiia Init I1 positioning Body posture during measurement Start the measurement Important facts about Blood Pressure measurement How to evaluate your Blood Pressure Some frequently asked questions... -
Page 3: Introduction
The monitor is designed for at least two years of reliable service. Readings taken by the Aktiia Init I1 are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information and provides step-by-step instructions for using the product. -
Page 4: Indications For Use
Indications for use Aktiia Init I1 is indicated to be used for measuring blood pressure and heart rate in adults with arm circumference ranging from 22cm to 42cm (about 8¾˝-16½˝). Aktiia Init I1 is indicated for home use. Contraindications Aktiia Init I1 should not be used by any person who is pregnant or may possibly be pregnant. -
Page 5: Important Safety Information
Please read the important safety information in this user manual before using the device. Any serious incident occurring in relation to Aktiia Init I1 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 be used only for the purpose described in this manual. • If you are allergic to polyester, nylon or plastic, don‘t use this device. The manufacturer cannot be held liable for damage caused by • Check the device before use, do not use the device if it is damaged in any way.
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Page 7: Package Content
Package content Your Aktiia Init I1 is supplied in a box containing the following items : 1x Aktiia Init I1 1x USB cable 1x User Manual ON/OFF BUTTON THE DEVICE Latest version of Aktiia Init I1 user manual can also be found online at : LIGHT www.aktiia.com/ifu USB CONNECTOR PORT 6 – EN... -
Page 8: Power Supply And Charging
Power supply and charging Device USB connector port The battery of Aktiia Init I1 is a built-in rechargeable li-polymer battery. The battery capacity is 1000 mAh. If charging for the first time (immediately after purchase or after USB microB connector not having used it for a long time), or if the battery stops working USB cable while using the device, make sure to charge it fully. -
Page 9: Correct Aktiia Init I1 Positioning
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 Init I1 is at the same height as your heart. Your Aktiia Init I1 is positioned on the inner side of your arm, over the artery and the logo is at its top. -
Page 10: Start The Measurement
Start the measurement 1. Download the free Aktiia App. Scan the QR code below or go to the Google Play store or Apple App Store, then download and install the Aktiia App. 2. Create a user account on Aktiia App (or login to your existing user account). Open the Aktiia App on your mobile device and follow the instructions to register and set up your personal account. -
Page 11: Important Facts About Blood Pressure Measurement
Important facts about Blood Pressure measurement Systolic Diastolic Blood pressure is the pressure applied by circulating blood on the walls of blood vessels. Blood pressure is blood discharging blood entering mainly due to the work of the heart pumping blood through the circulatory system. When the ventricles contract vein artery and pump blood out of the heart, the blood pressure reaches its maximum value in the cardiac cycle, which is... -
Page 12: How To Evaluate Your Blood Pressure
How to evaluate your Blood Pressure Aktiia Init I1 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 and diagnosis based on your personal blood pressure results. The following classifications are based on measurements taken on a seated person after few minutes of rest. ... - Page 13 13. 2 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...
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Page 14: Some Frequently Asked Questions
Some frequently asked questions Why does my blood pressure measurements differ throughout the day? Individual blood pressure naturally varies through regular daily life (see §10). It is also affected by the way you tie your cuff and your measurement position, so please try take the measurements under the same conditions. If you are under prescription drugs, your blood pressure may vary more. Why do I get a different blood pressure at home compared to the hospital? The blood pressure is different even throughout the day due to weather, emotion, exercise, etc. -
Page 15: Unpair Your Device
Unpair your device During the pairing procedure, the Aktiia Init I1 is linked to your Aktiia account. In case you wish to reset the pairing and allow another person to use the device you must reset the pairing first. To complete the unpairing procedure you should : 1. Login to your account 2. Tap on the device tab 3. Tap on the button with the three dots 4. -
Page 16: Troubleshooting
Your Aktiia Init I1 is warranted to be free from defects in materials and workmanship within two years from the date of purchase when used in accordance with the provided instructions. The warranty extends only to the end user. We will, at our option, repair or replace without charge Aktiia Init I1 covered by the warranty. -
Page 17: Specifications
SYS : 60mmHg~230mmHg (8.0kPa~30.7kPa) Measurement range DIA : 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value : (40-199)beat / m inute Aktiia Init I1 complies with the accuracy requirements of ISO 81060-2 Accuracy Blood Pressure : Mean error ± 5mmHg / Standard deviation ± 8mmHg (according to the clinical evaluation) Pulse value : ± 5% A temperature range of : +5°C to +40°C A relative humidity range of 15% to 90%, non-condensing, Normal working condition but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of ... - Page 18 Weight Approx.271g External dimensions Approx.74.3mm×28.2mm×133mm Attachment USB Cable and user manual Mode of operation Continuous operation Degree of protection Type BF applied part IP22 : The first number 2 : Protected against solid foreign objects of 12,5mm Ф and greater. Protection against The second number : Protected against vertically falling water drops when enclosure titled up to 15º. ingress of water Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to 15º on either side of the vertical.
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Page 19: Emc And Rf Statements
EMC and RF statements Aktiia Init I1 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the following section. The device is suitable for home healthcare environments. Aktiia Init is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. -
Page 20: Electromagnetic Compatibility Information
The user of Aktiia Init should ensure that it is used in such an environment. Aktiia Init 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 21 Guidance and manufacturer’s declaration - electromagnetic immunity Aktiia Init is intended for use in the electromagnetic environment specified below. The user of Aktiia Init should ensure that it is used in such an environment. Aktiia Init 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. Immunity test 60601-1-2 test levels Compliance level ± 8 kV contact...
- Page 22 0,15 MHz – 80 MHz 0,15 MHz – 80 MHz Conduced RF IEC61000-4-6 6 V in ISM and amateur radio bands between 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz 0,15 MHz and 80 MHz 80 % AM at 1 kHz 10 V / m 10 V / m Radiated RF 80 MHz – 2,7 GHz 80 MHz – 2,7 GHz IEC61000-4-3 80 % AM at 1 kHz 80 % AM at 1 kHz Note ...
- Page 23 Pulse modulation 704-787 LTE Band 13,17 b) 217Hz GSM 800 / 9 00, Pulse modulation 800-960 TETRA 800, iDEN 820, b) 18Hz CDMA 850, LTE Band 5 1720 GSM 1800, CDMA 1900, Pulse modulation 1845 1700-1990 GSM 1900, DECT, LTE b) 217Hz Band 1,3,4,25, UMTS 1970...
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Page 24: Ce Compliance
CE compliance This device complies with the following regulations and normative documents / s tandards : EU RED STATEMENT : Hereby, Aktiia SA, declares that the device is compliance with the essential requirements and other relevant provisions of RE Directive 2014 / 5 3 / E U. EN 60601-1:2006+A1:2013 / IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1 : General requirements for basic safety and essential ... -
Page 25: 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. 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 26: Safety Information
Safety information The signs below might be in the user manual, labeling or other component with your Aktiia Init I1. 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 27: 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 28 Version 12 – 03.12.2020 Aktiia Init I1 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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