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i-Kare iBP-130 User Manual

Intelligent blood pressure monitor
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"i-Kare" Intelligent Blood Pressure
Monitor
Model: iBP-130 / User Manual
Be sure to read this instruction before you use the device.
Ver.0.63 Issue date: 2017/07/28

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Summary of Contents for i-Kare iBP-130

  • Page 1 “i-Kare” Intelligent Blood Pressure Monitor Model: iBP-130 / User Manual Be sure to read this instruction before you use the device. Ver.0.63 Issue date: 2017/07/28...

  • Page 2: Table Of Contents

    Table of Contents   Table of Contents  ........................  ‐  1 ‐   Know Your Unit .........................  ‐  3 ‐   Introduction ..........................  ‐  6 ‐   Precautions ..........................  ‐  7 ‐   1. Part Description ........................  ‐  9 ‐   2. Before Start .........................  ‐  11 ‐   2.1 Battery Installation ......................  ‐  11 ‐  ...
  • Page 3   8. Main Functions  ........................  ‐  27 ‐   Appendix I ..........................  ‐  30 ‐   Appendix II ..........................  ‐  37 ‐   Appendix III ..........................  ‐  39 ‐   ‐ 2 ‐...

  • Page 4: Know Your Unit

    18 (including pregnant patients) and patient population with arm circumference ranging from 9" to 13". Neonatal and pediatric patients are not recommended to use this monitor. The iBP-130 comes with the following accessory: Arm Cuff  ...
  • Page 5  Council Directive: 93/42/EEC M5 as amended by 2007/47/EC   The device complies with R&TTE directive.     ISO 9001:2008; Quality management Systems – Requirement.   ISO 13485:2003; Medical devices – Quality management systems – Requirements for regulatory  purposes.   EN ISO 14971:2012; Medical devices – Application of risk management to medical devices.   EN 980:2008; Graphical symbols for use in the labeling of medical devices.   EN 60601‐1:2006+A1:2013; Medical electrical equipment, Part1: General requirements for safety.   EN60601‐1‐2:2015;  Medical  electrical  equipment  –  Part1‐2  General  requirements  for  safety‐collateral standard: Electromagnetic compatibility‐requirements and test.   EN 60601‐1‐6:2010+A1:2015; Medical electrical equipment ‐‐ Part 1‐6: General requirements for  basic safety and essential performance - Collateral standard: Usability.  EN60601-1-11:2015; Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
  • Page 6 Distributor BIOSTAR MICROTECH INTERNATIONAL CORP. 3F., 108-2, Min Chuan Rd., Hsin Tien Dist., New Taipei City, Taiwan (R.O.C.) Tel: 886 2 2218-0150 EU representative Manufacturer BIOSTAR MICROTECH INTERNATIONAL CORP.  Biostar Microtech Netherlands BV Archimedesweg 2A, 5928PP Venlo, 3F., 108‐2, Min Chuan Rd., Hsin Tien Dist.,  The Netherlands New Taipei City, Taiwan(R.O.C) Read this manual  ...

  • Page 7: Introduction

    Introduction  Before operating this monitor, please carefully read the instruction to use it correctly.  This product is designed for blood pressure monitoring and applied to adults. It is not applied to neonates and infants.  This device complies with IEC 60601-1 standard for medical products. ...

  • Page 8: Precautions

    Precautions Warning: Do not use the product for any purpose other than measuring blood pressure. Warning: This product is designed for use by adults. Do not use on neonatal and infants. Warning: People suffering from a serious problem of blood flow, vascular disease or pregnant woman should consult their physician before measuring their blood pressure themselves.
  • Page 9 Please be aware that the cuff and its pressurization may cause temporary intererence to blood flow and injury to the patient. Disposal: Follow the national requirement to dispose unit.   ‐ 8 ‐...

  • Page 10: Part Description

    1. Part Description Main Unit Battery Power Compartment Menu Down Start LCD Display Air Jack   ‐ 9 ‐...
  • Page 11 Arm Cuff LCD Display Heartbeat / Irregular heartbeat Symbol Systolic Blood Body Motion Pressure Symbol Record Diastolic Blood Symbol Pressure Transmission Symbol Pulse Pumping/Leaking Air Symbol Finger Print Indicator Bar Symbol Battery Date/Time Indicator   ‐ 10 ‐...

  • Page 12: Before Start

    2. Before Start 2.1 Battery Installation Make sure the monitor is switched off and turn the main unit over (battery compartment up). Remove the battery cover. Install 4 “AA” size batteries so the + (positive) and - (negative) polarities match the polarities of the battery compartment as indicated. Replace the battery cover.
  • Page 13 Press "Power" to turn on the monitor. Then press “Menu” three times and you will see "year" flash on the bottom of the display. Press “Menu”   three times Please press “Up” or “Down” to select the correct “Year.” After setting “Year”, press “Menu” to save the change and move to “Month”. Now you shall see "Month"...

  • Page 14: Fingerprint Registration

    2.3 Fingerprint registration  This monitor is designed to recognize up to 5 fingerprints.  Press and hold “Power " at least 3 seconds. Press "Menu" once and symbol will be illuminated then place your finger in the finger print receptor.  If this particular finger has not been registered, the display will show P_ and that means you can select your user ID by pressing "Up / Down".

  • Page 15: Fingerprint Recognition

     When the user ID and symbol are flashing on the display, the settings is completed and press “Power” to exit. Please note, if the finger has been registered, the display will show you user ID associated with that finger. Please note that the display will only show available user IDs, which means if someone has been measuring his / her blood pressure under a particular user ID, the display will not show this ID.

  • Page 16: Take A Measurement

    3. Take a Measurement To avoid damage of vessels and tissue, do not frequently measure blood pressure. 3.1 Correct Posture  Before being the measurement, please ensure you are relaxed as much as possible. We recommend that users should rest for at least 5-minute before the measurement. ...

  • Page 17: Applying The Arm Cuff

    3.2 Applying the Arm Cuff Please ensure there is no wound on your arm to avoid further injury by cuff being over it. Remove constricting clothing and place cuff on bare left upper arm without impeding the blood flow. Ensure there is no barrier around arm cuff and follow the figure below to apply the arm cuff correctly.

  • Page 18: Take A Measurement

    3.3 Take a Measurement  Please keep correct posture and press “Power”. symbol will be flashing and you may place your registered finger in the finger print receptor.  The display will show your user ID and press "Start" to begin the measurement. ...

  • Page 19: Manual Inflate Function

    3.4 Manual Inflate Function If your systolic pressure is known to be more than 220 mmHg please follow procedures. Press and hold the “Up" button to enter “Manual Inflate” mode before the cuff inflated to 180mmHg. When cuff pressure reaches 290 mmHg, the cuff will be deflating and measurement starts. If you do not wish to inflate to 290mmHg, you can release “Up"...

  • Page 20: Review Record

    3.5 Review record  Press "Power" to turn on the monitor. When symbol flashes and you may place your registered finger in the finger print receptor.  Your user ID will be shown on the display. Press “Menu” once and wait for a second to enter “Review Mode”.
  • Page 21 Press “Up” or “Down” to select the records.  If you wish to exit the “Review Mode”, please press “Power” to exit.   ‐ 20 ‐...

  • Page 22: How To Transmit Data

    4. How to Transmit Data 4.1 Wireless transmission  To transmit data wirelessly, please install APP on your tablet or smart phone. After turn on blood pressure monitor and press "Menu" once, the symbol " " will be appeared on the display. ...

  • Page 23: Care And Maintenance

    5. Care and Maintenance To keep your intelligent blood pressure monitor in the best condition and protect the product from damage, follow the directions listed below:  Do not subject the main unit to extreme hot or cold temperatures, humidity or direct sunlight. ...

  • Page 24: Error Indicators And Troubleshooting

    6. Error Indicators and Troubleshooting 6.1 Error Indicators Error code Cause Correction Repeat measurement. Remain still Severe body movement during and do not talk during measurement. measurement. Refer to “Taking a Measurement”. Arm cuff not applied correctly; Apply the arm cuff correctly. Refer to arm cuff connects the main unit “Applying the Arm Cuff”.
  • Page 25 Error code Cause Correction When systolic or diastolic Measure blood pressure with other pressure is over than 230 mmHg device. or is less than 40 mmHg. Replace new batteries. Refer to Batteries are worn out. “Battery Installation.”   ‐ 24 ‐...

  • Page 26: Troubleshooting

    6.2 Troubleshooting Problem Cause Solutions No power. No battery Replace the four batteries. Refer to “Battery Installation.” No display appears on Wrong battery polarity the product. Batteries are worn The cuff does not inflate. Batteries are worn Replace the four batteries. Refer to “Battery Installation.”...

  • Page 27: Specifications

    7. Specifications Model i-Kare iBP-130 Intelligent blood pressure monitor3 Display LCD digital display Measuring method Oscillometric system Pumping Pressure: 0 to 290 mmHg Pressure range   Measuring Pressure: At Least 40-230 mmHg Measuring pulse rate range Pulse rate: 40 to180 pulses / min Accuracy Pressure: ±...
  • Page 28 8. Main Functions 1. It provides five users for blood pressure measurement and management.  The finger print receptor will identify users' IDs or simply press “Up” or “Down” to select IDs. The user IDs are P1, P2, P3, P4, and P5. After setting completed, please press “Power”...
  • Page 29 9. Basics of Blood Pressure What is blood pressure? Blood pressure is a measure of the force of blood flowing against the walls of the arteries. Arterial blood pressure is constantly changing during the course of the heart’s cycle. The highest pressure in the cycle is called the Systolic Blood Pressure;...
  • Page 30 High Blood Pressure High Blood Pressure, or hypertension, is a medical condition in which the arterial blood pressure is elevated. High blood pressure can be classified as "primary", meaning that no medical cause can be found, or as "secondary", meaning that it is caused by other conditions that affect the kidneys, arteries, heart or endocrine system.
  • Page 31 The iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) should assure that it is used in such an environment.
  • Page 32 Not applicable typical home lines IEC 61000-4-11 healthcare Voltage interruptions: Voltage interruptions: environment. 0 % U ; 250/300 cycle Not applicable If the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX= 0-9) requires continued operation during power mains interruptions,...
  • Page 33 Power frequency(50, 30 A/m 30 A/m The iBP-130, 60 Hz) magnetic field 50 Hz or 60 Hz 50 Hz, 60 Hz iBP-131, IEC 61000-4-8 iBP-132, iBP-133, iBP-143, iBP-1XX(XX= 0-9) power frequency magnetic fields should be at levels...
  • Page 34 The iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) should assure that is used in such and environment.
  • Page 35 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is used exceeds the applicable RF compliance level above, the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) should be observed to verify normal operation.
  • Page 36 The iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is intended for use in an electromagnetic environment (for home healthcare) in which radiated RF disturbances are controlled. The customer or the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile...
  • Page 37 ENCLOSURE PORT IMMUNITY The iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the iBP-130, iBP-131, iBP-132, iBP-133, iBP-143, iBP-1XX(XX=0-9) should assure Compliance Test...
  • Page 38 Appendix II FCC warning statement 15.21 Federal Communications Commission (FCC) Statement The user manual or instruction manual for an intentional or unintentional radiator shall caution the user that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment.
  • Page 39 The identification of the product:This blood pressure monitor is intended for home use as well as ambulance. Product Name: Intelligent Blood Pressure Monitor Model: iBP-130 Technical Support: Jian Bang Lee Address:2F, No108-2, Min Chuan Road, Hsin Tien Dist. New Taipei City 231, Taiwan...
  • Page 40 Appendix III NCC Warning Statement 根據NCC低功率電波輻射性電機管理辦法規定: 第十二條 經型式認證合格之低功率射頻電機，非經許可，公司、商號或使用者均不得 擅自變更頻率、加大功率或變更原設計之特性及功能。 第十四條 低功率射頻電機之使用不得影響飛航安全及干擾合法通信；經發現有干擾現 象時，應立即停用，並改善至無干擾時方得繼續使用。 前項合法通信，指依電信法規定作業之無線電通信。 低功率射頻電機須忍受合法通信或工業、科學及醫療用電波輻射性電機設備 之干擾。     ‐ 39 ‐...

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