iHealth Ease BP3L User Manual
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iHealth Ease BP3L User Manual

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Wireless Blood Pressure Monitor (BP3L)
User Guide

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Summary of Contents for iHealth Ease BP3L

  • Page 1 Wireless Blood Pressure Monitor (BP3L) User Guide...

  • Page 2: Package Contents

    INTRODUCTION Thank you for selecting the iHealth Ease Wireless Blood Pressure Monitor. The iHealth Wireless Blood Pressure Monitor is a fully automatic arm cuff wireless blood Pressure monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your mobile device to measure, track and share vital blood pressure data.

  • Page 3: Parts And Display Indicators

    CONTRAINDICATION It is not recommended for people with serious arrhythmia to use this wireless blood pressure monitor. PARTS AND DISPLAY INDICATORS Air port Rubber tube cufftubing Connector Cuff Emergency Stop Button and LED SPECIFICATIONS 1. Product name: Wireless Blood Pressure Monitor 2.

  • Page 4: General Safety And Precautions

    Systolic: 60 - 260 mmHg Diastolic: 40 - 199 mmHg Pulse rate: 40 - 180 beats/minute 9. Accuracy: Pressure: ±3 mmHg Pulse rate: ±5% 10. Wireless communication: Bluetooth Smart Frequency Band: 2.402 - 2.480 GHz 11. Environmental temperature for operation: 10°C - 40°C (50°F - 104°F) 12.
  • Page 5 b )The application of the cuff on any limb with intravascular access or therapy, or an arteriovenous (A-V) shunt. c )The application of the cuff on the arm on the side of a mastectomy. d )Simultaneous use with other medical monitoring equipment on the same limb. e ) The blood circulation of the user needs to be checked.

  • Page 6: Battery Handling And Usage

    microwave oven, etc.) 9. If the blood pressure measurement (systolic or diastolic) is outside the rated range specified in part SPECIFICATIONS, the app will immediately display a technical alarm on the screen. In this case, repeat the measurement ensuring that the proper measurement procedures are followed and/or consult with your medical professional.
  • Page 7 • You should charge the battery when the battery is less than 25% charged. Overcharging the battery may reduce its lifetime. • When in charging mode, the LED on the device will be displayed with different colors indicating the charging status. See the table below for details. Status Indicator Monitor Status Flashing green light...

  • Page 8: Troubleshooting

    TROUBLESHOOTING PROBLEM POSSIBLE CAUSE SOLUTION Low Battery Battery is less than 25% Charge the battery Re-test and contact your health professional if blood Blood pressure is outside of measurement range pressure measurement is still outside of normal range Display reads Arm or monitor was moved during test Re-test, make sure not to move your arm or the monitor “ERROR”...

  • Page 9: Care And Maintenance

    Avoid high temperature and direct sunlight. Do not immerse the monitor in water as this will result in damage to the monitor. Do not attempt to disassemble this monitor. Battery replacement should only be performed by a qualified iHealth technician. To do otherwise will void...

  • Page 10: Warranty Information

    WARRANTY INFORMATION The iHealth Wireless Blood Pressure Monitor is warranted to be free from defects in materials and workmanship within one year 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 the iHealth Wireless Blood Pressure Monitor covered by the warranty.
  • Page 11 The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by iHealth Lab Inc. is under license. Other trademarks and trade names are those of their respective owners.

  • Page 12: Contact And Customer Service

    (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by iHealth Labs Inc. would void the user’s authority to operate the product.
  • Page 13 This product is approved in accordance to R&TTE directive transmitter. Hereby, [iHealth Labs Inc.], declares that this [BP3L EASE] is in compliance with the essentialrequirements and other relevant provisions of Directive 1999/5/EC. Directive 1999/5/EC declaration of conformity can be downloaded on the following link: https://www.ihealthlabs.eu/support/certications...

  • Page 14: Other Standards And Compliances

    OTHER STANDARDS AND COMPLIANCES The Wireless Blood Pressure Monitor corresponds to the following standards: IEC 60601-1:2005 corr.1(2006)+corr.2(2007)/EN 60601-1：2006/A11: 2011(Medical electrical equipment – Part 1: General requirements for safety); IEC 60601-1-2:2007 /EN 60601-1-2:2007 /AC:2010 (Medical electrical equipment – Part 1: General requirements for safety;...

  • Page 15: Electromagnetic Compatibility Information

    ELECTROMAGNETIC COMPATIBILITY INFORMATION Table 1 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture’s declaration - electromagnetic emissions The BP3L is intended for use in the electromagnetic environment specified below. The customer or the user of the BP3L should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
  • Page 16 Table 2 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration - electromagnetic immunity The BP3L is intended for use in the electromagnetic environment specified below. The customer or the user of the BP3L should assure that it is used in such an environment. Electromagnetic environment - Compliance level IMMUNITY test...
  • Page 17 Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration - electromagnetic immunity The BP3L is intended for use in the electromagnetic environment specified below. The customer or the user of the BP3L should assure that it is used in such an environment. Compliance IMMUNITY test IEC 60601test level Electromagnetic environment - guidance...
  • Page 18 by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
  • Page 19 The BP3L is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BP3L can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment(transmitters) and the BP3L as recommended below, according to the maximum output power of the communications equipment.

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