Mindray EPA001 Operator's Manual
  1. Manuals
  2. Brands
  3. Mindray Manuals
  4. Monitor
  5. EPA001
  6. Operator's manual
Mindray EPA001 Operator's Manual

Mindray EPA001 Operator's Manual

Wearable ecg monitor
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
 
Wearable ECG Monitor
Operator's Manual
I

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the EPA001 and is the answer not in the manual?

Questions and answers

Related Manuals for Mindray EPA001

Summary of Contents for Mindray EPA001

  • Page 1   Wearable ECG Monitor Operator’s Manual...
  • Page 2 © Copyright 2014-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2016-4.
  • Page 3 Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.
  • Page 4 PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
  • Page 5 Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and 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. This manual is based on the maximum configuration and therefore some contents may not apply to your product.

  • Page 6: Table Of Contents

        Contents 1.1.1 Warnings  .......................  2   1.1.2 Cautions  ........................  3   1.1.3 Notes ........................  3   1.2 Equipment Symbols ......................  4   2.1 Product introduction ......................  1   2.1.1 Apply scope ......................  1   1.2.1 Applied Parts ......................  1   2.2 Product appearance  ......................  2   3.1 Installation ......................... ...
  • Page 7     Safety Safety Information WARNING Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. CAUTION Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

  • Page 8: Warnings

    1.1.1 Warnings WARNING  This equipment can not be used for infant whose weight is less than 10 Kg.  Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.

  • Page 9: Cautions

    1.1.2 Cautions CAUTION  Make sure that the operating environment of the equipment meets the specific requirements.  To prolong the service life of the wquipment, please don’t put it under the sunshine for a long time.  To ensure patient safety, use only parts and accessories specified in this manual. ...

  • Page 10: Equipment Symbols

    1.2 Equipment Symbols General warning sign DATE OF MANUAFACTURE Serial number AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive. Note: The product complies with the Council Directive 2011/65/EU.

  • Page 11: Product Introduction

        Safety 2.1 Product introduction Wearable ECG monitor contain adhesive ECG recorder，ECG sensor. The adhesive ECG recorder collect ECG signal via ECG sensor. The data collected is stored in ECG recorder. It can be transmitted to protocol compatible device or APP. 2.1.1 Apply scope Can be used for measuring, recording and storing human ECG data, for applications that require long continuous records of patients ECG data.

  • Page 12: Product Appearance

    2.2 Product appearance Picture 错误！文档中没有指定样式的文字。-1 Adhesive ECG recorder front Picture 错误！文档中没有指定样式的文字。-2 Adhesive ECG recorder back...

  • Page 13: Installation

        Installation and Maintenance 3.1 Installation WARNING  The software copyright of the equipment is solely owned by us. No organization or individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission. 3.1.1 Unpacking and Checking Before unpacking, examine the packing case carefully for signs of damage.

  • Page 14: Environmental Requirements

    1.2.2 Environmental Requirements The operating environment of the equipment must meet the Environmental Specification in Appendix B. 3.1.2 Power requirements The power used for this equipment must meet the Power Specification in Appendix B. WARNING  Make sure that the operating environment and power of the equipment meets the specific requirements.

  • Page 15: Disinfection

    WARNING  Please clean the surface under the rules abbove. Otherwise, it may damage the shell or the print of the equipement 3.2.2 Disinfection Disinfect the equipment as required in your hospital’s servicing schedule. Cleaning equipment before disinfecting is recommended.

  • Page 16: Preparation Before Use

        Operations 4.1 Preparation before use Please shake the ECG recorder and observe the LED light before use.  The green light flicker means the ECG recorder is normal.  The red light flicker every 3 seconds means the ECG recorder is malfunction. ...
  • Page 17 错误！文档中没有指定样式的文字。‐3  Picture ECG recorder installatiosketch map with one channel ECG sensor Installation process shows as below: 1.Tear off the tape marked①. 2.Stick the ECG recorder to the accessory. 3.Tear off the tape marked②. 4.Stick the ECG recorder with accessory nearby to heart such as A, B, C area in the picture. 5.Tear off the tape marked③.

  • Page 18: View Ecg Data

     The ECG recorder can work with one channel ECG sensor or two channel ECG sensor. Please use of accessories approved by Mindray.  Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected.

  • Page 19: Charge The Ecg Recorder

    NOTES  The ECG recorder will enter sleep mode. There is no need to power off it. 4.5 Charge the ECG recorder Please charge the ECG recorder under following conditions: First use There is no light indicator when shake the ECG recorder. Reuse the ECG recorder over one month between last use.

  • Page 20: Offline Data Transimission

    NOTES  The charger that model is EPC001 has no Battery volume indicator. Only can check the battery is full or not by ECG recorder’s indicator. 4.6 Offline data transimission The data stored in ECG recorder can be exported by Bluetooth of charger. A computer and export software are needed as well.

  • Page 21: Frequence Questions Management

    Frequence Questions Management 5.1 Frequence Questions Management Malfunction Possible cause resolvent phenomena Battery low volume Battery used out Charge ECG recorder Work time is short, 1.Battery low volume 1.Charge ECG recorder, then use. only a couple of hours 2.ECG recorder malfunction 2.Contact Manufacturer to fix it。...
  • Page 22 Adhesive ECG recorder has a rechargeable Lithium-ion battery as work power. The battery icon on Mindray health APP shows the volume status: When the remaining volume of battey is less than 10%, the red light on the ECG recorder will flash.

  • Page 23: Ecg Sensor

    Accessory 7.1 ECG Sensor The accessories show as the table below. The lifetime of the accessories is 2years.  Part description model Type Manufacturer MR.Wear sigle channel EPA001 Sigle use ECG sensor Mindray MR.Wear two channels EPA002 Sigle use ECG sensor WARNING  Use accessories specified in this chapter. Using other accessories may cause damage to the equipment or not meet the claimed specifications.

  • Page 24: Charger

    Please select a computer or adapter that fulfills IEC60950 or related industry safety standards to supply the charger.  Only use the charger approved by Mindray. The charger complies with the requirements of IEC60601-1.  The metal material stuff can not be placed on the charger. The charger can not use for other device except the ECG recorder.

  • Page 25: A Product Specifications

        A Product Specifications Safety Specifications The ECG recorder is classified, according to IEC60601-1: Class I, equipment energized from an internal electrical Type of protection against electrical power source. shock Degree of protection against electrical Type CF shock Continuous Mode of operation Degree of protection against harmful IPX7...

  • Page 26: Physical Specifications

    Physical Specifications Length：87±5mm Size Width：32±3mm Height：6±1mm ≤10g Weight Standard interface, include ECG leads signals and Bluetooth signal Interface Display, Recorder and Storage Specification Display A least one lead ECG wave and equipment status information will be display on mobile phone or other mobile device. Recorder mode Real time record Storage mode...

  • Page 27: B Emc And Radio Regulatory Compliance

        B EMC and Radio Regulatory Compliance The device meets the requirements of IEC 60601-1-2. NOTE  Using accessories, transducers and cables other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the device. ...
  • Page 28 RF emissions CISPR 11 Class B The device is suitable for use in all establishments , domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Not apply IEC61000-3-2 Voltage Fluctuations/Flicker Not apply Emissions IEC 61000-3-3...
  • Page 29 Surge IEC ±1 kV line(s) to line(s) Not apply 61000-4-5 ±2 kV line(s) to earth Voltage dips, short <5 % U (>95 % dip in Not apply interruptions and ) for 0.5 cycle voltage variations on power supply 40 % U (60 % dip in U input lines IEC for 5 cycles...
  • Page 30  Where, is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey ,should be less than the compliance level in each frequency range Interference may occur in the vicinity of...
  • Page 31    of transmitter （W） 0.01 0.12 0.12 0.23 0.38 0.38 0.73 1.20 1.20 2.30 3.80 3.80 7.30 12.00 12.00 23.00 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using 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.

  • Page 32: Radio Regulatory Compliance

    This  Bluetooth  device  complies  with  Canadian  ICES‐001.  Cet  appareil  ISM  est  conforme  a  la  norme NMB‐001 du Canada.    The device including Bluetooth module FCC and Industry Canada Radio Compliance: This device  complies with Part 15 of the FCC Rules and RSS‐210 of Industry Canada. Operation is subject to  the following two conditions: (1) this device may not cause harmful  interference, and (2) this device must accept any interference received, including interference  that  may  cause  undesired  operation.  Any  changes  or  modifications  to  this  equipment  not  expressly approved by Mindray may cause harmful radio frequency interference and void your  authority to operate this equipment.    The maximum antenna gain permitted complies with the e.i.r.p. limits as stated in RSS‐210.  The  maximum  antenna  gain  permitted  complies  with  the  e.i.r.p.  limits  specified  for  point‐to‐point operation, as stated in RSS‐210.     ...

  • Page 33: C Symbols And Abbreviations

        C Symbols and Abbreviations Symbols ampere decibel gram hertz kilo kilopascal meter millimeters millisecond millivolt milliwatt second volt Ω watt minus － percent per; divide; or ～ power plus ＋ equal to ＝ ＜ less than greater than ＞...

  • Page 34: Abbreviations

    Abbreviations electrocardiograph Medical Device Directive magnetic resonance imaging...
  • Page 35    ...

This manual is also suitable for:

Epa002Epc001Epc002

Table of Contents