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.
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 3 BEFORE YOU START Power Supply and Charging Tie the cuff 11 MEASUREMENT Start Measurement 15 INFORMATION FOR USER Tips for Measurement Maintenance 16
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? 17 SPECIFICATIONS 20 FCC STATEMENT 22 COMPLIED EUROPEAN STANDARDS LIST 23 EMC GUDIANCE 25
INTRODUCTION General Description Thank you for selecting AKTIIA arm type blood pressure monitor (AKTIIA INIT I1). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Readings taken by this mornitor are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.
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 “THE OPERATION GUIDE MUST BE READ” Symbol for “TYPE BF APPLIED PARTS” Symbol for “COMPLIES WITH MDD 93/42/EEC REQUIREMENTS” Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist.
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.
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.
CAUTION * Do not wash the cuff in a washing machine or dishwasher! * The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times. * It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
Symbols meaning mmHg mmHg mmHg Systolic Blood Pressure Diastolic Diastolic Blood Pressure Systolic Mean Mean arterial pressure HR Heart rate High blood pressure Low blood pressure The average value of arterial blood pressure during a cardiac cycle Blood pressure monitor is detecting a heartbeat during measurement.
Monitor Components USB CONNECTOR PORT Component list of pressure measuring system 1 PCBA 2 Air pipe 3 Pump 4 Valve 5 Cuff List THE DEVICE 1.Blood Pressure Monitor (AKTIIA INIT I1) 2.USB Cable LIGHT 3.
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.
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. 2. If charging for the & time (immediately after purchase or after not having used it for a long time), or if the battery stops working while using the device, make sure to charge it fully. 1. Connect the USB microB connector of the USB cable to the device's USB connector port. 2.
* The battery of AKTIIA INIT I1 is built-in rechargeable lithium-ion battery, please do not disassemble it by the unauthorized maintenance personel. * Under normal usage, it can charge power about 300 times, if the battery cannot charge the power normally or the blood pressure monitor cannot be used normally, please connect with the authorized maintenance personel.If measured three times per day, and the battery is fully charged, it can be used for about 23 days.
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. Position the edge of the cuff about 2cm~3cm from elbow. 5. Fasten the cuff around your arm, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate. 6.
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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). 1.Switch the button to the “ON” side to turn on the monitor,and the blue light will blink. Note: If the button is on the “OFF” side, there is no reaction when you press any button. 2. Open Aktiia cuff app on your mobile device.
INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Within 1 hour after dinner or drinking Immediate measurement after tea, coffee, smoking Within 20 minutes after taking a bath When talking or moving your fingers In a very cold environment When you want to discharge urine Maintenance To obtain the best performance, please follow instructions below. Put in a dry place and avoid the sunshine. Avoid intense shaking and collisions.
ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure. 1. How to evaluate your Blood Pressure AKTIIA monitor is not intended to be a diagnostic device.
1.2 Europe The European Society of Hypertension (ESH) has created the following guide for classifying blood pressure values. Note: Various factors such as age, obesity and medical condition should be considered for a correct evaluation.Consult with your physicians for an accurate assessment and diagnosis of your health condition.
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. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious.
SPECIFICATIONS Power supply 3.7V 1000mAH Built-in rechargeable li-polymer battery ,5V 1A AC Adaptor(optional) Measurement mode Oscillographic testing mode Measurement range Rated cuff pressure: 0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement pressure: SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute Accuracy Normal working condition Storage & transportation condition Pressure: 5°C-40°C within±3mmHg(0.
Measurement perimeter of the arm Weight External dimensions Attachment Mode of operation Degree of protection Protection against ingress of water Software version Device classification About 22cm-42cm Approx.271g Approx.74.3mm×28.2mm×133mm USB Cable and user manual Continuous operation Type BF applied part IP22: The first number 2: Protected against solid " [$ number: Protected against vertically falling water drops when enclosure titled up to 15º.
FCC STATEMENT FCC Statement FCC ID: OU9TMB1973BS This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
COMPLIED STANDARDS LIST Complied Standards List Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices Application of risk management to medical devices Labeling EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied.
Clinical investigation Usability Software life-cycle processes Bio-compatibility EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test 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 performance - Col
EMC GUDIANCE EMC Guidance The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments. Warning: Don’t near activate HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions Compliance Group 1 Class [ B ] Class A Comply IEC 61000-3-3 26
Table 2 Guidance and manufacturer’s declaration – electromagnetic Immunity Immunity Test IEC 60601-1-2 Test level Electrostatic discharge (ESD) IEC 61000-4-2 ±8 kV contact ±2 kV, ±4kV, ±8 kV, ±15 kV air Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV signal input/output 100 kHz repetition frequency Surge IEC61000-4-5 ±0.5 kV, ±1 kV differential mode ±0.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 0 % UT; 0,5 cycle. At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°.0 % UT; 1 cycle and 70 % UT; 25/30 cycles; Single phase: at 0°.0 % UT; 250/300 cycle 0 % UT; 0,5 cycle. At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0 % UT; 1 cycle and 70 % UT; 25/30 cycles; Single phase: at 0°.
Table 3 Guidance and manufacturer’s declaration - electromagnetic Immunity IMMUNITY Test Band Service Modulation Modulation Distance (m) TEST Radiated RF Frequency (MHz) (W) IEC61000-4-3 LEVEL (MHz) (Test (V/m) specifications for Pulse TETRA ENCLOSURE 1.8 380-390 400 385 0.3 27 modulation b) PORT 18Hz IMMUNITY to FM c) ± 5kHz GMRS 460，deviation 1kHz RF wireless 2 0.3 28 450 430-470 FRS 460 communications sine equipment) Pulse 710 LTE Band 0.2 0.
1720 1845 17001990 1970 2450 24002570 GSM 1800; CDMA 1900; Pulse GSM 1900; modulation b) DECT;LTE 217Hz Band 1,3,4, 25; UMTS 2 0.3 28 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 2 0.3 28 0.2 0.3 9 Pulse modulation 217 Hz 5240 5500 5785 51005800 WLAN 802.
FCC ID: OU9TMB1973BS Aktiia SA Rue de la Pierre-à-Mazel 39, 2000 Neuchâtel, Switzerland EC REP Medidee Services GmbH Hohnenweg 9, 78098 Triberg im Schwarzwald, Germany Version:1.
