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iHerz iMove User Manual

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automatic
BLOOD PRESSURE
MONITOR
model iMove
model iMove

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Summary of Contents for iHerz iMove

  • Page 1 BLOOD PRESSURE MONITOR model iMove model iMove...
  • Page 2 Thank you for choosing Automatic Blood Pressure Monitor TM iHerz ® model iMove. We are sure that having appraised worthily the high quality and reliability of this device you will become a regular user of the products of Italian Trademark TM iHerz ®...

  • Page 3: What Is Blood Pressure

    IMPORTANT INFORMATION ON BLOOD PRESSURE AND ITS MEAS- UREMENT What Is Blood Pressure? Blood pressure is the pressure that your blood extends to the vascular walls. Blood pressure is necessary to provide for constant blood flow inside the body. Thanks to it the cells get oxygen that provides for their normal functioning.

  • Page 4: Which Values Are Normal

    One of the features of the hypertension is its ability to remain unno- ticed for the patient at its early stages. That’s why the self control of the blood pressure is so important. With the illness progressing, head- aches and regular dizziness appear, the sight declines, the function- ing of vitals (encephalon, heart, kidneys, blood vessels) breaks down.

  • Page 5: Blood Pressure Rate Indicator

    ADVANTAGES OF AUTOMATIC BLOOD PRESSURE MONITOR MODEL IMOVE Blood Pressure Rate Indicator Blood pressure rate indicator is located along left side of the display. The classification corresponds to 6 ranges described in the table of the section «Which values are normal?».

  • Page 6: Multiple Users

    Multiple Users 2 users can make measurements and store data together. Memory allows up to 60 results for each user enabling to display average results, which include quite long period of time. There is no need to write down and store the results on hard copies every time after measurement. GETTING READY FOR MEASUREMENT Safety Precautions This device is intended for adult use in homes only.
  • Page 7 deviation. Please consult your physician about the result. * When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking too frequent and consecutive multiple measurements;...
  • Page 8 * This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application. *This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
  • Page 9 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). * Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.

  • Page 10: Components Of Your Blood Pressure Monitor Kit

    KEEP THIS MANUAL DURING THE WHOLE LIFETIME OF THE DEVICE COMPONENTS OF YOUR BLOOD PRESSURE MONITOR KIT The blood pressure monitor kit includes Automatic Blood Pressure Monitor model iMove, 2 batteries 1,5 V (AAA), user’s manual, war- ranty card, kit box. Description of the Blood Pressure Monitor LCD DISPLAY...

  • Page 11: Installing And Replacing The Batteries

    Installing and Replacing the Batteries • Slide off the battery cover. • Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2 x AAA batteries). • Replace the battery cover. Replace the batteries whenever the below happen •...
  • Page 12 Diastolic blood pres- Low blood pres- sure sure Pulse display Pulse in beats per minute Deflation symbol The cuff is deflat- ing. Memory Indicate it is in the memory mode and which group of memory it is. Measurement Unit of the blood pressure mmHg Measurement...

  • Page 13: Setting The Date And Time

    Heartbeat Blood pressure monitor is detect- ing a heartbeat during measure- ment. User 1/User G/User 2 Start measure- ment for User 1/ User G/User 2 Motion indicator Motion may result in an inaccurate measurement Setting the Date and Time It is important to set the clock before using your blood pressure moni- tor, so that a time stamp can be assigned to each record that is stored in the memory.

  • Page 14: Measurement Procedure

    6. Repeat steps 2 and 3 to confirm the [MEASUREMENT UNIT]. 7. After confirming the meausrement unit, the LCD will display all the settings you have done once again and then turn off. MEASUREMENT PROCEDURE ATTENTION • Find time to relax by sitting in a quiet atmosphere for some time before measurement.

  • Page 15: Fitting The Cuff

    Fitting the Cuff Select a pressure cuff size that corresponds to the circumference of your shoulder (measured with a tight fit in the middle of the shoulder). The size M (13.5 - 21.5 cm) is a size fitting the majority of people. 1.Remove all accessories (watch, bracelet, etc) from your wrist.

  • Page 16: Measuring Procedure

    • For example, take daily measurements at approximately the same time, on the same wrist, or as directed by a physician. Measuring Procedure When the monitor is off, press the “START/STOP” to turn on the moni- tor, and it will finish the whole measurement .(Take User 1 for example) LCD display Adjust the zero Inflating and...

  • Page 17: Delete Memories

    2. Press “MEM” button again, it will display the latest measurement result, date and time. Press “MEM” button again, it will display the next record,and so on. During the process of displaying the results, if there is no operation, the blood pressure monitor will turn off in one minute.

  • Page 18: Error Messages/Troubleshooting

    3. If there is no record, the right display will show. ERROR MESSAGES/ TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your wrist blood pres- sure monitor. If the products not operating as you think it should, check here before arranging for service.
  • Page 19 E 1 shows The cuff is not Refasten the secure. cuff and then measure again. E 2 shows The cuff is too Refasten the tight. cuff and then measure again. E 3 shows The pressure Relax for a of the cuff is moment and excess.

  • Page 20: Warning Message

    “out ” shows Out of meas- The measure- urement range ment result is out of the measurement range (SYS:60mmHg Warning to 230mmHg; message or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute) CARE AND MAINTENANCE In order to get the best performance, please follow the instructions below.
  • Page 21 Avoid dusty and unstable temperature environment Using wet cloths to remove dirt Avoid washing the cuff Disinfection: If required (for example, in a hospital setting), disinfection of the pressure cuff twice per week is recommended. Disinfect the interior of the pressure cuff (the surfaces that come into contact with the patient’s skin) with the use of a soft cloth soaked in ethyl alcohol (75-90%) and wait for the pressure cuff to dry up.

  • Page 22: Symbol Information

    SYMBOL INFORMATION SYMBOL REFERENT Consult instruction for use Manufacturer Manufacturing date Serial number Direct current Caution, consult accompanying documents Dispose accordance with requirements of your country The cuff is type BF applied part European representative CE mark Recycle The Green Dot is the license symbol of a European network of industry-funded systems recycling...

  • Page 23: Technical Specifications

    TECHNICAL SPECIFICATIONS Power supply Battery powered mode: 2*AAA batteries (3V DC) Display mode Digital LCD V.A.32mm×45mm 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 Pressure: 5°C-40°C within ±...

  • Page 24: Warranty

    DSTU EN 1060-3:2015 “Non-Invasive Sphygmomanometer.” Part 3. Paragraph 9.2. WARRANTY Your Automatic Blood Pressure Monitor Model iMove is warrant- ed for 5 years from date of purchase. Warranty for the cuff is 1 year from the date of purchase. The warranty does not apply to...
  • Page 25 COMPLIED STANDARDS LIST Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices -Application of risk man- agement 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.

  • Page 26: Performance Requirements

    Performance EN ISO 81060-1:2012 Non-invasive requirements sphygmomanometers - Part 1: Require- ments and test methods for non-automated measurement type EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplemen- tary requirements for electro-mechanical blood pressure measuring systems IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non- invasive sphygmomanometers...

  • Page 27: Emc Guidance

    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 cytotoxicity ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization EMC Guidance...
  • Page 28 RF emissions Group 1 The device uses RF energy CISPR 11 only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B The device is suitable for use in CISPR 11 all establishments, other than domestic and those directly con-...
  • Page 29 Surge line(s) to line(s) to line(s): Mains power quality IEC61000-4-5 line(s): ±1 kV ±1 kV should be that of a line(s) to earth: 100 kHz typical commercial ±2 kV repetition or hospital environ- 100 kHz frequency ment. repetition frequency Voltage dips, 0%UT;...
  • Page 30 Conducted 150 kHz to Portable and mobile RF com- 80 MHz: kHz to munications equipment should IEC 61000- 3 Vrms 80 MHz: be used no closer to any part of 6Vrms (in 3 Vrms the device, including cables, than 6Vrms (in the recommended separation distance calculated from the amateur...
  • Page 31 a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accu- racy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 32 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 33 Test Band Service a) Modula- Modulation Distance IMMU- Radi- Fre- tion b) NITY ated RF quency (MHz) TEST IEC61000- (MHz) LEV- 4-3 (Test speci (V/m) fications for ENCLO- 380- TETRA Pulse SURE modula- PORT IM- tion b) MUNITY to 18Hz RF wireless commu- nications...
  • Page 34 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance be- tween the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal.

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