Praxisdienst LEPU MEDICAL BP2 User Manual

Automatic upper arm blood pressure monitor

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Automatic Upper Arm
Blood Pressure Monitor
Model BP2/BP2A
User Manual
English|Deutsch|Italiano|Español|Français

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Summary of Contents for Praxisdienst LEPU MEDICAL BP2

  • Page 1 Automatic Upper Arm Blood Pressure Monitor Model BP2/BP2A User Manual English|Deutsch|Italiano|Español|Français...
  • Page 2: Table Of Contents

    User Manual Contents 1. The Basics ............2 1.1 Safety ............2 2. Introduction ............6 2.1 Intended Use ..........6 2.2 Contraindications ........6 2.3 About the Product ........7 2.4 Unpacking ..........7 2.5 Symbols ............ 8 3. Using the Monitor ..........10 3.1 Charging the Battery ........
  • Page 3: The Basics

    1. The Basics This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observing this manual is a prerequisite for proper product performance and correct operations, which ensures patient and operator safety. 1.1 Safety Warnings and Tips Before using the device, please ensure that you have...
  • Page 4 Do not place this device in pressure vessels or gas  sterilization devices.  Do not dismantle the device because this could cause  damage or malfunctions or impede device operations. This device is not intended for use by people (including ...
  • Page 5 consult your doctor immediately if you experience symptoms that could indicate a serious disease. Do not self-diagnose or self-medicate based on this  device without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
  • Page 6 through the artery. This may cause pain, numbness, or a temporary red mark on the arm. This condition will appear especially when measurements are repeatedly taken. Any pain, numbness, or red marks will disappear with time. Do not apply the cuff on an arm with another ...
  • Page 7: Introduction

    2. Introduction 2.1 Intended Use The product is intended to be used for measuring, displaying, reviewing, and storing ECG and blood pressure variations in the home or healthcare facilities. ECG and Blood pressure variation is intended for use with adult. The data and results provided by this device are for precheck screening purposes only and cannot be directly used for diagnosis or treatments.
  • Page 8: About The Product

    2.3 About the Product 1. Start/Stop button Power On/Off  Press to Start/Stop measuring blood pressure.  2. Function button Press to start the ECG measurement.  Press and hold for 2 seconds to review historical data.  3. Display screen 4.
  • Page 9: Symbols

    2.5 Symbols Symbol Description Manufacturer Date of manufacture Serial number Indicates a medical device that is not to be disposed of as unsorted municipal waste. Follow Instructions for Use. Type BF Applied Part No alarm system MRI unsafe. Presents hazards in all MR environments as device contains strongly ferromagnetic materials.
  • Page 10 This product complies with the rules and regulations of the Federal Communication Commission. Non-ionizing radiation Our products and packaging can be recycled, don't throw them away! Find where to drop them off on www.quefairedemesdechets.fr site (Only applicable for French market). Heartbeat symbol Battery symbol Bluetooth symbol...
  • Page 11: Using The Monitor

    Low signal amplitude or noise Lead off when ECG is measuring The recorded ECG satisfies a common regular pattern. The recorded ECG is erratic. It may be caused by heart issues or other conditions. 3. Using the Monitor 3.1 Charging the Battery Use the USB cable to charge the monitor.
  • Page 12 Remove any tight-fitting clothing from your arm.  A single measurement does not provide an accurate  indication of your true blood pressure. You need to take and record several results over a period of time. Try to measure your blood pressure at the same time ...
  • Page 13: Recording Ecg

    3.2.4 Measuring Blood Pressure 1. Power on the blood pressure monitor. 2. Press the Start/Stop button to start taking blood pressure measurements. The monitor will automatically deflate the cuff slowly measurement while taking measurements. A typical takes about 30s. 4. The readings will be displayed when the measurement is finished.
  • Page 14 directions: Before using the ECG function, pay attention to the  following points to obtain precise measurements. The ECG electrode must be positioned directly against  the skin. If your skin or hands are dry, moisten them using a  damp cloth before taking measurements.
  • Page 15 A. Right hand to left Leg B.Hand to hand C.Right hand to abdomen D.Right hand to chest To start an ECG Recording: 1. Put your right palm on the right side electrodes of the monitor. 2. Place the left side electrodes to the body position that you desired to measure.
  • Page 16: Reviewing History Records

    3.3.3. Turn on/off Heartbeat Sound The buzzer beeps when a heartbeat is detected while recording ECG. You can turn on/off the heartbeat sound on the App. 3.4 Reviewing History Records You can review the history results and replay the recorded ECG waveform on the History screen.
  • Page 17: Troubleshooting

    The monitor has built-in Bluetooth wireless connectivity, which enables exporting measurement records to mobile phones and tablets running iOS or Android. Hold the function button and Start/Stop button simultaneously to enable Bluetooth and start pairing it to your smart device. 4.Troubleshooting Problem Possible Cause...
  • Page 18: Maintenance

    service. The ECG cable is off, or Check the ECG the body parts are not cable, or place Check the placed on the the electrodes connection electrodes closely closer to your enough. body part. The pressure exerted Hold the on the electrode is not device stably stable or too much.
  • Page 19: Storage

    clean the electrodes. Do not use gasoline, thinners, or similar solvents to  clean your monitor and arm cuff or other components. 5.3 Storage Keep your monitor and other components in the storage case when not in use. Store your monitor and other components in a clean, ...
  • Page 20 Drop test 1.0 m Physical Size (main unit) 135mm(L)×45mm(W)×20mm(H) Weight (main unit) 240 g Adult cuff: 22-42cm Cuff size Small adult cuff (optional): 17-22cm Adult cuff (optional): 22-32cm Wireless connectivity Built-in Bluetooth 4.0 BLE Power Supply Charge input USB Type-C, DC 5V Battery type Rechargeable lithium-polymer battery Battery run time...
  • Page 21: Electromagnetic Compatibility

    Heart rate range 30 - 250/min ±2 /min or ±2%, Heart rate accuracy whichever is greater Storage Blood pressure records ECG records Bluetooth RF Frequency range 2.402 – 2.480 GHz Max RF power -10 dBm 7. Electromagnetic Compatibility The device meets the requirements of EN 60601-1-2. Warnings and Tips Using accessories other than those specified in this ...
  • Page 22 Portable and mobile communication equipment may  affect device performance. Other devices that have RF transmitters or sources may  affect this device (e.g. cell phones, PDAs, and PCs with wireless functionality). Guidance and Declaration - Electromagnetic Emissions The Blood Pressure Monitor is intended for use in the electromagnetic environment specified below.
  • Page 23 Electromagnetic Immunity IEC60601 test Complian environment - test level ce level guidance Floors should be wood, concrete ± 8kV or ceramic tile. If contact Electrostatic ± 8kV contact floors are discharge covered with ±2kV, (ESD) ±2kV, ±4kV, synthetic ±4kV, IEC 61000-4-2 ±8kV, ±15kV air material, the ±8kV,...
  • Page 24 (30% dip in U for 25/30 cycles at 0° 0% U (100% dip in U for 250/300 cycles at 0° Power frequency magnetic fields Power should be at frequency levels (50/60 HZ) 30 A/m, 30 A/m, characteristic of a magnetic 50/60Hz 50/60Hz typical location in...
  • Page 25 distance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distances:               80MHz to 800MHz        800MHz to 2.7GHz Radiated Where, P is the maximum 10V/m...
  • Page 26 Note 1: At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz;...
  • Page 27 d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the Blood Pressure Monitor The Blood Pressure Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

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