Aktiia INIT I1 User Manual Download

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User Manual

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.

Thank you very much for selecting AKTIIA Blood Pressure Monitor AKTIIA INIT I1.

Arm Type

Summary of Contents for INIT I1

Page 1: ... 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 Thank you very much for selecting AKTIIA Blood Pressure Monitor AKTIIA INIT I1 Arm Type ...

Page 2: ... Contraindications Measurement Principle Safety Information Symbols meaning Monitor Components List BEFORE YOU START Power Supply and Charging Tie the cuff MEASUREMENT Start Measurement INFORMATION FOR USER Tips for Measurement Maintenance Component list of pressure measuring system ...

Page 3: ...s my blood pressure fluctuate throughout the day Why do I get a different blood pressure at home compared to the hospital Is the result the same if measuring on the right arm SPECIFICATIONS 22 FCC STATEMENT 23 25 COMPLIED EUROPEAN STANDARDS LIST EMC GUDIANCE What you need to pay attention to when you measure your blood pressure at home ...

Page 4: ... using the product 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 d for indoor use only Contraindications 1 The device should not be used by any person who may be suspected of or is pregnant 2 The device is not suitable for use on patients with implanted electrical devices such as cardiac...

Page 5: ...advice Symbol for Authorised Representative in the European Community EC REP SN Symbol for TYPE BF APPLIED PARTS Symbol for THE OPERATION GUIDE MUST BE READ Symbol for COMPLIES WITH MDD 93 42 EEC REQUIREMENTS Symbol for MANUFACTURER Symbol for SERIAL NUMBER Symbol for DIRECT CURRENT Symbol for MANUFACTURE DATE Caution These notes must be observed to prevent any damage to the device Symbol for RECY...

Page 6: ...rescribed by a doctor Consult your doctor if you have any question about your blood pressure When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation the results might be inaccurate Please consult your physician about the result When using this device please pay attention to the following situation which may interr...

Page 7: ...le anesthetic mixture with air of with oxygen or nitrous oxide Warning No servicing maintenance while the ME equipment is in use The patient is an intended operator The patient can measure data and charge power under normal circumstances and maintain the device and its accessories according to the user manual To avoid measurement errors please avoid the condition of strong electromagnetic field ra...

Page 8: ...must only be serviced repaired and opened by individuals at authorized sales service centers Please report to AKTIIA if any unexpected operation or events occur Keep the unit out of reach of infants young children or pets to avoid inhalation or swallowing of small parts It is dangerous or even fatal Be careful to strangulation due to cables particularly due to excessive length At least 30 min requ...

Page 9: ...re Diastolic Blood Pressure Low blood pressure Blood pressure monitor is detecting a heartbeat during measurement Heart rate The average value of arterial blood pressure during a cardiac cycle Systolic Diastolic Mean Mean arterial pressure HR 8 mmHg mmHg mmHg ...

Page 10: ...onents LIGHT THE DEVICE ON OFF BUTTON USB CONNECTOR PORT Component list of pressure measuring system 1 PCBA 2 Air pipe 3 Pump 5 Cuff 4 Valve List 1 Blood Pressure Monitor AKTIIA INIT I1 2 USB Cable 3 User Manual 9 ...

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 10 ...

Page 12: ...e Charge at least once every three months If the battery loses all its charge it may not be rechargeable When powering on the monitor the light doesn t light up 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 t...

Page 13: ... changeable Only charge the battery in accordance with the user instructions supplied with the blood pressure monitor Avoid charging your blood pressure monitor in extremely high or low temperatures Do not use your blood pressure monitor while you are charging it Do not attempt to disassemble the blood pressure monitor or force open the built in battery Do not clean the blood pressure monitor when...

Page 14: ...pwards Sit upright in a chair and take 5 6 deep breaths 7 Helpful tips for Patients especially for Patients with Hypertension Rest for 5 minutes before first measuring Wait at least 3 minutes between measurements This allows your blood circulation to recover Take the measurement in a silent room The patient must relax as much as possible and not move and talk during the measurement procedure The c...

Page 15: ...14 ...

Page 16: ...side there is no reaction when you press any button 2 Open Aktiia cuff app on your mobile device 3 Press on START PAIRING to launch the pairing procedure 4 Once the pairing is done the battery level information will be displayed in the screen 5 Press on START INITIALIZATION to launch the measurement 6 In case of recording stop or failure during the measurement press on TRY AGAIN 7 If the recording...

Page 17: ...ons Use the slightly damp cloth to remove the dirt Avoid immersing it in the water Clean it with a dry cloth in case Avoid dusty environment and unstable temperature surrounding Avoid washing the cuff 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 wan...

Page 18: ... might be higher These charts are not intended to provide a basis for any type of diagnosis or emergency assessment these charts only depict different classifications of blood pressure Consult your physician for an interpretation and diagnosis based on your personal blood pressure results press artery vein blood discharging Systolic relax blood entering Diastolic Contact a physician if your blood ...

Page 19: ...IMAL LESS THAN 120 AND LESS THAN 80 Dark Green Light Green NORMAL 120 129 AND OR 80 84 Yellow ELEVATED 130 139 AND OR 85 89 Orange HIGH BLOOD PRESSURE STAGE I 140 159 AND OR 90 99 Light Red HIGH BLOOD PRESSURE STAGE 2 HIGH BLOOD PRESSURE STAGE 3 160 179 HIGHER THAN 180 AND OR AND OR 100 109 HIGHER THAN 110 Dark Red Note Various factors such as age obesity and medical condition should be considered...

Page 20: ...ntion to when you measure your blood pressure at home If the cuff is too tight or too loose If the cuff is tied properly If the cuff is tied on the upper arm If you feel anxious Taking 2 3 deep breaths before beginning will be better for measuring Advice Relax yourself for 4 5 minutes until you calm down Is the result the same if measuring on the right arm It is ok for both arms but there will be ...

Page 21: ...g 0 4kPa Pulse value 5 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 A temperature range of 5 C to 40 C A relative humidity range of 15 to 90 non condensing but not requiring a water vapour partial pressure greater than 50 hPa An atmospheric pressure range of 700 hPa to 1060 hPa...

Page 22: ...red Mode Internally Powered ME Equipment AC Adaptor charged Mode optional AC Adaptor shall comply with the requirement of IEC 60601 1 or 60950 Class II ME Equipment IP22 The first number 2 Protected against solid number Protected against vertically falling water drops when enclosure titled up to 15º Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up...

Page 23: ...ference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving...

Page 24: ...al performance Collateral standard Electromagnetic disturbances Requirements and tests EN ISO 81060 1 2012 Non invasive sphygmomanometers Part 1 Requirements and test methods for non automated measurement type EN 1060 3 1997 A2 2009 Non invasive sphygmomanometers Part 3 Supplementary requirements for electro mechanical blood pressure measuring systems Risk management Labeling User manual General R...

Page 25: ...l devices EN 62304 2006 AC 2008 IEC 62304 2006 A1 2015 Medical device software Software life cycle processes Clinical investigation Usability Software life cycle processes Bio compatibility ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process ISO 10993 5 2009 Biological evaluation of medical devices Part 5 Tests for in vitro cytot...

Page 26: ...ified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation 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 i...

Page 27: ...er s declaration electromagnetic emissions RF emissions CISPR 11 Group 1 Class B Class A Comply Compliance Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 RF emissions CISPR 11 Emissions test 26 ...

Page 28: ...de Table 2 Compliance level Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC61000 4 5 1 kV signal input output 100 kHz repetition frequency IEC 60601 1 2 Test level 2 kV 4kV 8 kV 15 kV air 2 kV for power supply lines Not Applicable 100 kHz repetition frequency 0 5 kV 1 kV 2 kV common mode 0 5 kV 1 kV differential mode Not Applicable 27 ...

Page 29: ...Hz 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Radiated RF IEC61000 4 3 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 0 UT 250 300 cycle Voltage dips short interruptions and voltage variations on power supply input lines IEC 6...

Page 30: ... communications equipment Band MHz Service Modulation Modulation W Distance m IMMUNITY TEST LEVEL V m 380 390 TETRA 400 Pulse modulation b 18Hz 1 8 450 430 470 GMRS 460 FRS 460 FM c 5kHz deviation 1kHz sine 2 0 3 28 710 704 787 745 780 LTE Band 13 17 Pulse modulation b 217Hz 0 2 0 3 9 810 870 930 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18Hz 2 0 3 28 29 ...

Page 31: ...GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217Hz 2 0 3 28 2 0 3 28 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 5240 5500 5785 5100 5800 WLAN 802 11 a n Pulse modulation 217 Hz 0 2 0 3 9 30 ...

Page 32: ...FCC ID OU9TMB1973BS Version 1 0 EC REP Aktiia SA Rue de la Pierre à Mazel 39 2000 Neuchâtel Switzerland Medidee Services GmbH Hohnenweg 9 78098 Triberg im Schwarzwald Germany ...

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