Lepu Medical ER1-LB User Manual
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Lepu Medical ER1-LB User Manual

Dynamic ecg recorder
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Dynamic ECG Recorder
User Manual

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Summary of Contents for Lepu Medical ER1-LB

  • Page 1 Dynamic ECG Recorder User Manual...
  • Page 2 Contents User Manual............English 1-28 Benutzerhandbuch..........Deutsch 29-57 Manuale d'uso..........Italiano 58-87 Manual de usuario........Español 88-116 Manuel de l'utilisateur........Français 117-146...

  • Page 3: Table Of Contents

    Table of Contents 1. The Basics ................ 2 2. Introduction ............... 5 3. Using Instructions ............11 4. Maintenance ..............16 5. Accessories ..............18 6. Specifications ..............19 7. FCC Warning ..............20 8. Electromagnetic compatibility ........22...

  • Page 4: The Basics

    1. The Basics This manual contains the instructions necessary to operate the product safely in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. Safety Warnings and Cautionary Advice Before using this equipment, please read this manual...
  • Page 5 Do not strongly collide or crush the device. If the casing  is broken, stop using it. This device cannot be placed in a pressure vessel or gas  sterilization equipment. Do not disassemble or modify the device without  authorization of the manufacturer, otherwise it may cause machine malfunction or affect the normal operation of the device.
  • Page 6 ECG measurement requires more professional and complete measurements. This device cannot be used to diagnose a disease directly.  Please consult your doctor. We recommend that you record your ECG curve and the  results of the measurements and provide them to your doctor if necessary.

  • Page 7: Introduction

    2. Introduction Name and Model Name: Dynamic ECG recorder Model: ER1-LB Intended Use The Dynamic ECG recorder is intended to measure, review and store adults’ ECG data at home or in healthcare environment. The device continuously records and stores ECG and activity data for at least 7 days at a time.
  • Page 8 About ER1-LB Figure 1 1. Right sign When wearing, the side marked "R" should be on the right hand side of the wearer. 2. Display screen The display screen demonstrates ECG waveform, and shows heart rate, battery power and charging status.
  • Page 9 F. Press and hold for 3 seconds to mark ECG events accompanied by a vibration (Wearing the device) Note: This function is off by default and can be turned on in the App. 4. Electrode buckle For connecting chest strap, disposable electrocardiogram electrode or charging cable.
  • Page 10 Protected against spraying water and IP22 against access to hazardous parts with a tool, per IEC 60529. MRI unsafe. Presents hazards in all MR environments as device contains strongly ferromagnetic materials. Follow Instructions for Use. This product complies with the rules and regulations of the Federal Communication Commission.
  • Page 11 Use-by date Temperature limit Humidity limitation Atmospheric pressure limitation Display Indications Powering on Battery status reminder Device ID display Symbols Start measurement on the screen ECG waveform demonstration Heart rate measurement ECG Marker Lead off...
  • Page 12 Invalid waveform Battery level below 15% or 5% Switch to home screen, low battery display Charging Charge complete Data upload reminder Data storage Data download via Bluetooth USB data transfer in progress Powering off Standby screen Lead off countdown...

  • Page 13: Using Instructions

    Product structure and composition This product is mainly composed of Dynamic ECG recorder main unit, charging cable, chest strap (optional), and disposable ECG electrodes. 3. Using Instructions Before use Warnings and Cautionary Advice Before taking measurements, please pay attention to the following points to ensure the accuracy of the measurement data.
  • Page 14 Warnings and Cautionary Advice Please save the box and packing materials for future  transportation or storage. When handling packaging materials, local regulations or  the hospital's waste disposal system must be followed and the packaging materials should be kept out of the reach of children.
  • Page 15 Figure 2 Chest Strap measurement method: Attach the main unit to the strap and then wear them beneath the precordium with the R end on the right side. Figure 3 Precautions: a. Before use, please check whether the single-use ECG electrode is within the validity period.

  • Page 16: Data Export Function

    3.4.2 Measuring steps 1) Select a measurement method and wear the device according to the above instructions. 2) The device automatically turns on and starts recording when it detects the ECG signal. The screen displays the ECG waveform and heart rate. 3) Keep recording for at least 5 minutes.
  • Page 17 can be viewed smoothly, please export the data in time after each measurement is completed. Charging This device uses a rechargeable lithium battery. It is charged by connecting a laptop or a power adapter with the charging cable. Charging steps: 1) Connect the device with the USB clip.

  • Page 18: Maintenance

    4. Maintenance Warnings and Cautionary Advice Have the device repaired by authorized service centers only, otherwise its warranty is invalid. Warranty The product is warranted to be free from defects in materials and workmanship within warranty period when used in accordance with the provided instructions.

  • Page 19: Troubleshooting

    When the battery exceeds the service life or no longer  holds the power, contact the manufacturer for disposal. Follow local laws for proper disposal of the battery. Cleaning Dynamic ECG recorder and straps need to be cleaned regularly (once a week). Carefully swab the device with a clean, soft cloth or cotton ball with 70% medical alcohol or water.

  • Page 20: Accessories

    Problem Possible Cause Recommended Action Measurement Please re-measure method is according to the incorrect Instructions in the manual waveform is disordered Please clean the ECG with large Poor contact of electrode according to the clutter ECG electrode method described in the manual 5.

  • Page 21: Specifications

    5. Disposable ECG electrodes should be in close contact with the skin. If itching, skin irritation or ulceration occurs, stop using it immediately. 6. The device uses specialized disposable ECG electrodes, and is not compatible with those on the market. Please contact customer service or agent if you need to purchase.

  • Page 22: Expected Service Life

    Lead type Single-use ECG electrode Lead Lead I Input impedance ≥10MΩ, 10Hz Linearity and dynamic 10mV (peak-to-valley) range Common mode rejection ≥60dB Frequency response 0.67 ~ 40 Hz Gain error Maximum error ±10% Physical Size 100mm×23mm×10 mm Packing size 172mm×113mm×59mm weight <20 g (with battery) Bluetooth connection support Built-in...
  • Page 23 (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.

  • Page 24: Electromagnetic Compatibility

    8. Electromagnetic compatibility The device meets the requirements of IEC 60601-1-2. Warnings and Cautions This device should not be used in the vicinity or on the  top of other electronic equipment such as cell phone, transceiver or radio control products. If you have to do so, the device should be observed to verify normal operation.
  • Page 25 Voltage public low-voltage power supply fluctuations/ flicker network that supplies buildings used emissions IEC for domestic purposes. 61000-3-3 Recommended separation distances between portable and mobile RF communications equipment and the A&D unit The Dynamic ECG recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 26 propagation is affected by absorption and reflection from structures, objects and people. Recommended separation distances between RF wireless communications equipment The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between RF wireless communications equipment and the device as recommended below, according to the...
  • Page 27 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF 5785 transmitter, as determined by electromagnetic site survey, should be less than the...
  • Page 28 The Dynamic ECG recorder is intended for use in the electromagnetic environment specified below. The customer or the user of The Dynamic ECG recorder should assure that it is used in such an environment. Immunity Electromagnetic Compliance 60601 test environment – guidance level test level Portable and mobile RF...
  • Page 29 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. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz;...
  • Page 30 Guidance and manufacturer’s declaration – electromagnetic immunity The Dynamic ECG recorder is intended for use in the electromagnetic environment specified below. The customer or the user of The Dynamic ECG recorder should assure that it is used in such an environment. Electromagnetic Immunity IEC 60601 test...
  • Page 31 LEPU MEDICAL...

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