Lepu Medical ER2-S User Manual
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Lepu Medical ER2-S User Manual

Ecg recorder
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Summary of Contents for Lepu Medical ER2-S

  • Page 1 ECG Recorder User Manual...

  • Page 2: Table Of Contents

    Table of Contents 1. The basics ................. 2 Safety ..............2 2. Introduction ...............5 Name and Model ..........5 Intended Use ............5 About ECG recorder ..........6 Symbols ..............8 Product structure and composition .....11 3. Using Instructions ............11 Before use ............11 Open box to check ..........11 Boot ..............12 Measuring process ..........12...

  • Page 3: 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. 1.1 Safety Warnings and Cautionary Advice Before using this equipment, please read this manual...
  • Page 4 Do not use acetone or other volatile solutions to clean the  device. 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 ...
  • Page 5 Do not self-diagnose and take medication based on the  measurements of this device without consulting your doctor. In particular, do not take new medications without prior permission. This device is not a substitute for professional heart or  other organ function measurement equipment. Medical ECG measurement requires more professional and complete measurements.

  • Page 6: Introduction

    2. Introduction 2.1 Name and Model Name: ECG recorder Model: ER2-S 2.2 Intended Use The ECG recorder is intended to record, display, store and transfer single-channel electrocardiogram(ECG) rhythms at home or in healthcare environment.

  • Page 7: About Ecg Recorder

    2.2.1 Contraindications: The product is not intended for use in patients with cardiac pacemakers or other implantable devices. 2.3 About ECG recorder Figure 1 1. Display screen It can display time, power, waveform and heart rate when measuring. 2. Logo on the right When measuring, the R mark is located on the right side of the user.
  • Page 8 Indicator Status Description Not activated  Out of battery  Flashing with the rhythm of the Recording your ECG  heartbeat Green light Fully charged Flashing every 5  seconds In standby mode  Flashing with the rhythm of the Recording your ECG ...

  • Page 9: Symbols

    2.4 Symbols Symbol Significance Type CF-Applied Part Manufacturer Date of manufacture Authorized representative in the European Community This product complies with the European Council EU 2017/745 (MDR) Authorized Representative in the United Kingdom Symbols on the UKCA marking device Caution, incorrect use may cause personal injury and damages of goods.
  • Page 10 Indicate separate collection for electrical and electronic equipment (WEEE). MRI unsafe. Presents hazards in all MR environments as device contains strongly ferromagnetic materials. Medical device Unique device identifier Use-by date Our products and packaging can be recycled, don't throw them away! Find where to drop them off on the www.quefairedemesdechets.fr site (Only applicable for French market).
  • Page 11 Complete five-minute measurement Saving data Data saved, view the results in the Measuring time less than 30s Battery status reminder Heart rate and waveform Indicate the state where measurement is stopped without data saving after 6 consecutive detection of non-human body measurement Low battery Power off...

  • Page 12: Product Structure And Composition

    2.5 Product structure and composition This product is mainly composed of ECG recorder main unit, charging base, and charging cable. Using Instructions 3.1 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 13: Boot

    box. Check the device for any mechanical damage and complete items. If you have any questions, please contact us immediately. Warnings and Cautionary Advice Please save the box and packing materials for future  transportation or storage. When handling packaging materials, local regulations or ...
  • Page 14 Figure 2 Wrong way of operation: a. Shake your hands at will b. Loose fingers during measurement 2) Lead II For a Lead II EKG, the left knee should contact one electrode and the right hand should contact the other electrode. Figure 3...
  • Page 15 3) Anterior Precordial Lead For an Anterior Precordial Lead, the device can be placed on the lower left side of the chest, just below the pectoral muscle. Figure 4 Note: Moisten hands and measuring area before measurement.  Please make sure that the “R” symbol is always on the ...

  • Page 16: Data Export Function

    2) Hold still for at least 30 seconds, the device will emit a short beep, at which point the measurement can be ended and the device will complete the data saving for 30 seconds to 5 minutes. 3) When the continuous contact exceeds 5 minutes, the device stops measuring and switches off automatically.
  • Page 17 Charging steps: 1. Connect the device with power adapter by the charging cable. 2. Connect the charging cable to the USB port with 5V output voltage. While charging, the indicator light will remain orange; when the charging is completed, the indicator light will turn green and flash every 5 seconds.

  • Page 18: Maintenance

    When the device is not in use for a long time, it is  necessary to periodically charge the device to maintain battery performance. Maintenance Warnings and Cautionary Advice Have the device repaired by authorized service centers only, otherwise its warranty is invalid. 4.1 Warranty The product is warranted to be free from defects in materials and workmanship within warranty period when used in...

  • Page 19: Cleaning

    If the battery leaks, keep your skin and eyes away from  the leaking fluid. If skin or eyes come into contact with leaking fluid, rinse your skin or eyes immediately and go to hospital for treatment. Do not throw the battery into fire, otherwise it may cause ...

  • Page 20: Accessories

    1. Please re-measure according to the 1. Measurement instructions in the waveform is method is manual disordered incorrect 2. Please clean the ECG with large 2. Poor contact of electrode according clutter ECG electrode to the method described in the manual.
  • Page 21 Temperature 5 ~ 45°C -25 ~ 70°C Relative humidity 10% ~ 95% 10% ~ 95% (non-condensing) Atmospheric pressure 700 ~ 1060 hPa 700 ~ 1060 hPa Degree of dust&water IP22 resistance Drop test 1.0 m Power supply Type of battery Rechargeable lithium polymer battery Battery specification 3.7Vd.c., 90mAh...

  • Page 22: Fcc Warnning

    5 years XPECTED SERVICE LIFE Bluetooth RF Frequency range 2.402 - 2.480 GHz Max RF power -10dBm 7. FCC Warning FCC ID: 2ADXK-3623 Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

  • Page 23: Electromagnetic Compatibility

    Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.
  • Page 24 guidance RF emissions CISPR Group 1 The ECG recorder uses RF energy 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 CISPR Class B The ECG recorder is suitable for use in all establishments, including domestic establishments and those...
  • Page 25 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. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
  • Page 26 distance Where P is the maximum output power rating of the ransmitter 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 an electromagnetic site survey, should be less than the...
  • Page 27 test level Portable and mobile RF communications equipment should be used no closer to any part of The ECG recorder, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance ] P 80MHz to 800MHz 3Vrms...
  • Page 28 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
  • Page 29 synthetic material, the relative humidity should be at least 30%. Electrical fast ± 2 kV for power transient/ supply lines n.a. n.a. burst IEC ± 1 kV for input/ 61000-4-4 output lines Surge ± 1 kV line to line n.a. n.a.
  • Page 30 Lepu Medical Technology (Beijing) Co., Ltd. Building 7, No.37 Chaoqian Rd., Changping District, Beijing, China 102200 Website: en.lepumedical .com Email: service-inlt@lepucloud.com inquiry@lepucloud.com Shenzhen Viatom Technology Co., Ltd. 501, Building B, Ganghongji High-tech Intelligent Industrial Park, No. 1008 Songbai Road, Xili Street, Nanshan District, Shenzhen, 518055, Guangdong, P.
  • Page 31 LEPU MEDICAL...

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