Aktiia INIT I1 User Manual
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Aktiia INIT I1 User Manual

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User Manual
Blood Pressure Monitor
AKTIIA INIT I1
Arm Type
Thank you very much for selecting AKTIIA Blood Pressure Monitor AKTIIA INIT I1.
Please read the user manual carefully and thoroughly to ensure the safe usage of this product. Keep the manual for your further reference in case
you have problems.

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Summary of Contents for Aktiia INIT I1

  • Page 1 Arm Type Thank you very much for selecting AKTIIA Blood Pressure Monitor AKTIIA INIT I1. Please read the user manual carefully and thoroughly to ensure the safe usage of this product. Keep the manual for your further reference in case...

  • Page 2: Table Of Contents

    Table of Contents INTRODUCTION General Description Indications for Use Contraindications Measurement Principle Safety Information Symbols meaning Monitor Components Component list of pressure measuring system List BEFORE YOU START Power Supply and Charging Tie the cuff MEASUREMENT Start Measurement INFORMATION FOR USER Tips for Measurement Maintenance...
  • Page 3 ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Why does my blood pressure fluctuate throughout the day? Why do I get a different blood pressure at home compared to the hospital? What you need to pay attention to when you measure your blood pressure at home? Is the result the same if measuring on the right arm? SPECIFICATIONS...

  • Page 4: Introduction

    Indications for Use The AKTIIA Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and and heart rate in adults with arm FLUFXPIHUHQFH UDQJLQJ IURP FP WR FP DERXW ôÝòÝ  ,W LV LQWHQGHd for indoor use only.

  • Page 5: Safety Information

    Safety Information The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using. Symbol for “TYPE BF APPLIED Symbol for “THE OPERATION PARTS” GUIDE MUST BE READ” Symbol for “ENVIRONMENT Symbol for “COMPLIES WITH PROTECTION - Electrical waste MDD 93/42/EEC REQUIREMENTS”...
  • Page 6 CAUTION * This device is intended for adult use in homes only. * The device is not suitable for use on neonatal patients, pregnant women,patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses.
  • Page 7 CAUTION * The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER is clinically investigated according to the requirements of ISO 81060-2:2013. * To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer. * This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown. * Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
  • Page 8 * The device doesn’t need to be calibrated within two years of reliable service. * If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of AKTIIA. Don’t open or repair the device by yourself in the event of malfunctions.

  • Page 9: Symbols Meaning

    Symbols meaning mmHg mmHg mmHg Systolic Systolic High blood pressure Blood Pressure Diastolic Diastolic Low blood pressure Blood Pressure The average value of arterial blood Mean Mean arterial pressure pressure during a cardiac cycle Blood pressure monitor is detecting a Heart rate heartbeat during measurement.

  • Page 10: Monitor Components

    Monitor Components Component list of pressure measuring system 1 PCBA 2 Air pipe 3 Pump USB CONNECTOR PORT 4 Valve 5 Cuff List 2.USB Cable 1.Blood Pressure Monitor THE DEVICE (AKTIIA INIT I1) LIGHT 3.User Manual ON/OFF BUTTON...
  • Page 11 4. Cuff (22cm-42cm) (Type BF Applied Part) (Please use AKTIIA authorized cuff. For the size of the actual cuff, please refer to the label on the attached cuff. CUFF (Type BF applied part)

  • Page 12: Before You Start

    BEFORE YOU START Power Supply and Charging 1. The battery of AKTIIA INIT I1 is built-in rechargeable li-polymer battery, the battery current is 1000 mAh. Device 2. If charging for the ¿UVW time (immediately after purchase or after not USB connector port having used it for a long time), or if the battery stops working while using the device, make sure to charge it fully.
  • Page 13 * Store and use the blood pressure monitor in a cool, dry and ventilated environment. Avoid to approach to fire and heat sources or the battery may explode. * Only AKTIIA's authorized AC Adaptor can be used ( Model: BLJ06L050100U-V) (Not included) to charge the power. You cannot use the blood pressure monitor during the process of charging.

  • Page 14: Tie The Cuff

    Tie the Cuff 1. Remove all accessories (watch, bracelet,etc) from your arm. If your physician has diagnosed you with poor circulation in your arm, use the other one. 2. Roll or push up your sleeve to expose the skin. 3. Apply the cuff to your arm with your palm facing up. 4.

  • Page 16: Measurement

    Start the Measurement Before you start the measurement, Download the Aktiia Cuff app from APP Store or Google Play, and turn on the Bluetooth. Install the APP, and register an account. Then set your personal information (Gender, Birthday, Height, Weight, Name and so on).

  • Page 17: Information For User

    INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Within 1 hour after Immediate measurement Within 20 minutes When talking or moving In a very cold environment When you want to dinner or drinking after tea, coffee, smoking after taking a bath your fingers...

  • Page 18: About Blood Pressure

    1. How to evaluate your Blood Pressure CAUTION 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 Contact a physician if your blood pressure value has reached a dangerous point for relevant interpretation of blood pressure results.

  • Page 19: Why Does My Blood Pressure Fluctuate Throughout The Day

    1.2 Europe BLOOD PRESSURE CATEGORY SYSTOLIC BP mmHg DIASTOLIC BP mmHg COLOR INDICATOR The European Society of Hypertension (ESH) has OPTIMAL LESS THAN 120 LESS THAN 80 Dark Green created the following guide NORMAL 120-129 AND/OR 80-84 Light Green for classifying blood ELEVATED 130-139 AND/OR...
  • Page 20 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. Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings. What you need to pay attention to when you measure your blood pressure at home? If the cuff is tied properly.

  • Page 21: Specifications

    SPECIFICATIONS 3.7V 1000mAH Built-in rechargeable Power supply li-polymer battery ,5V 1A AC Adaptor(optional) Measurement mode Oscillographic testing mode Rated cuff pressure: 0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement pressure: Measurement range SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute Pressure: Accuracy 5°C-40°C within±3mmHg(0.4kPa) Pulse value:±5% A temperature range of :+5°C to +40°C A relative humidity range of 15% to 90%,...
  • Page 22 Measurement perimeter About 22cm-42cm of the arm 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 IRUHLJQ REMHFWV RI PP DQG JUHDWHU 7KH VHFRQG Protection against number: Protected against vertically falling water...

  • Page 23: Fcc Statement

    This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. RED Statement:Hereby,Aktiia SA,declares that this AKTIIA INT I1 is compliance with the essential requirements and other relevant provisions of RE Directive 2014/53/EU.A copy of the full DoC is attached.

  • Page 24: Complied European Standards List

    COMPLIED STANDARDS LIST Complied Standards List EN ISO 14971:2012 / ISO 14971:2007 Medical devices Application of risk management Risk management to medical devices EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with Labeling medical device labels, labelling and information to be supplied. Part 1: General requirements User manual EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment -...
  • Page 25 EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test Clinical investigation procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential Usability performance - Collateral standard: Usability IEC 62366-1:2015 Medical devices - Part 1: Application of usability...

  • Page 26: Emc Gudiance

    Warning: 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 the equipment AKTIIA INIT I1, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 27 Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions Emissions test Compliance RF emissions Group 1 CISPR 11 RF emissions Class [ B ] CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/ Comply flicker emissions IEC 61000-3-3...
  • Page 28 Table 2 Guidance and manufacturer’s declaration – electromagnetic Immunity Immunity Test IEC 60601-1-2 Compliance level Test level Electrostatic ±8 kV contact ±8 kV contact discharge (ESD) ±2 kV, ±4kV, ±8 kV, ±15 kV air ±2 kV, ±4kV, ±8 kV, IEC 61000-4-2 ±15 kV air Electrical fast ±2 kV for power supply lines...
  • Page 29 Voltage dips, short 0 % UT; 0,5 cycle. At 0°, 45°, 90°, 0 % UT; 0,5 cycle. At 0°, 45°, 90°, interruptions and 135°, 180°, 225°, 270° and 315°.0 135°, 180°, 225°, 270° and 315°. voltage variations % UT; 1 cycle and 70 % UT; 25/30 0 % UT;...
  • Page 30 Table 3 Guidance and manufacturer’s declaration - electromagnetic Immunity IMMUNITY Test Band Service Modulation Modulation Distance (m) Radiated RF TEST Frequency (MHz) IEC61000-4-3 LEVEL (MHz) (Test (V/m) specifications for Pulse TETRA ENCLOSURE 380-390 modulation b) PORT 18Hz IMMUNITY to FM c) ± 5kHz GMRS 460，...
  • Page 31 GSM 1800; 1720 CDMA 1900; Pulse GSM 1900; 1845 1700- modulation b) DECT;LTE 1990 217Hz Band 1,3,4, 1970 25; UMTS Bluetooth, WLAN, 2400- Pulse 802.11 2450 2570 modulation b/g/n, RFID 217 Hz 2450, LTE Band 7 5240 WLAN Pulse 5100- 5500 802.11 modulation...
  • Page 32 FCC ID: OU9TMB1973BS Aktiia SA Rue de la Pierre-à-Mazel 39, 2000 Neuchâtel, Switzerland Medidee Services GmbH EC REP Hohnenweg 9, 78098 Triberg im Schwarzwald, Germany Version:1.0...

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