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Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland
901047 CARDIOPULMONARY ECG SYSTEM
901095 ECG ACQUISITION MODULE
0297
DIR 80012763 Ver. H
PRO ECG Recorder - User Manual
CardioPerfect
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY
13153 USA
www.welchallyn.com
Revision date: 2017-09

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Summary of Contents for Welch Allyn PRO ECG Recorder

  • Page 1 CardioPerfect PRO ECG Recorder - User Manual Regulatory Affairs Representative Welch Allyn, Inc. Welch Allyn Limited 4341 State Street Road Navan Business Park Skaneateles Falls, NY Dublin Road 13153 USA Navan, County Meath, www.welchallyn.com Republic of Ireland 901047 CARDIOPULMONARY ECG SYSTEM...
  • Page 2 Caution Copyright © Copyright 2017, Welch Allyn. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.
  • Page 3: Safety And Precautions

    Patient cables and PC connection cables are intended to be inserted and removed from the PRO ECG Recorder in a push / pull motion. Do not twist the cables. Damage to the cables and the PRO ECG Recorder will occur.
  • Page 4 Welch Allyn provides a number of high quality patient leads in varying termination styles. Use of these approved patient leads is required for electrical protection of the patient during cardiac defibrillation.
  • Page 5 CardioPerfect PRO ECG Recorder - User Manual Ensure the location of the electrode and associated cables provides maximum separation away from all sources of high-frequency energy. The best way to ensure patient safety is to completely remove all electrodes and cables from the patient when exposed to high- frequency energy.
  • Page 6: Accessories

    Accessories Use of accessories other than those recommended by Welch Allyn may compromise product performance. The Welch Allyn warranty can only be honored if you use Welch Allyn approved accessories and replacement parts. DIR 80012763 Ver. H...
  • Page 7: Warranty, Service, And Spare Parts

    For information about any Welch Allyn product, contact Welch Allyn Technical Support: http:// www.welchallyn.com/support. Before contacting Welch Allyn it is helpful to attempt to duplicate the problem and to check all accessories to ensure that they are not the cause of the problem.
  • Page 8: Limited Warranty Statement

    Welch Allyn will, at its discretion, repair or replace the defective Product or accessory free of charge. You must obtain a return authorization from Welch Allyn to return your Product before you send it to Welch Allyn’s designated service center for repair.
  • Page 9: Table Of Contents

    1. About the CardioPerfect PRO Cardiograph ..............12 Accessories ......................13 2. Installation ..........................15 To connect the cables to the PRO ECG Recorder: ............16 To disconnect the cables from the PRO ECG Recorder: ..........16 Connecting the patient cable to the electrode ............17 3.
  • Page 10 CardioPerfect PRO ECG Recorder - User Manual Conventions A safety symbol used on the device to highlight the fact that there are specific warnings or precautions associated with the device, which are not otherwise found on the device label. A WARNING in this manual indicates conditions or practices that, if not corrected immediately, could lead to illness, injury or death.
  • Page 11 Do not dispose of in trash, for devices Consult operating instructions/directions for use (DFU). A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days. Global Trade Item Number...
  • Page 12: About The Cardioperfect Pro Cardiograph

    CardioPerfect PRO ECG Recorder - User Manual 1. About the CardioPerfect PRO Cardiograph The Welch Allyn CardioPerfect PRO Cardiograph is specifically intended for the recording of standard 12-lead electrocardiograms of patients. The device is not suitable for direct cardiac application.
  • Page 13: Accessories

    Accessories Your CardioPerfect PRO cardiograph allows the use of a broad range of accessories; contact your local Welch Allyn Sales Office or your authorized Welch Allyn Dealer or Distributor. NOTE All part numbers may not be available in all countries.
  • Page 14 CardioPerfect PRO ECG Recorder - User Manual Component Description Purpose Patient Cables; signals SE-PC-IEC-CLIP CLIP style connector, 1 meter, CLIP style connector, 1.3 meters SE-PC-IEC-CLPL CLIP style connector, 1 meter SE-PC-AHA-CLIP CLIP style connector, 1.3 meters SE-PC-AHA-CLPL Patient Cables; RE-PC-IEC-BAN Banana style connector, ½...
  • Page 15: Installation

    Before you can start recording ECG’s with the CardioPerfect PRO cardiograph, you need to: 1. Install the applicable software (refer to the Welch Allyn CardioPerfect Workstation Installation User Manual) 2. Install the hardware, including the required drivers. (Please refer to the Resting ECG manual chapters 11 &...
  • Page 16: To Connect The Cables To The Pro Ecg Recorder

    The Prolink cable has 2 alignment keys and the Patient cable has 1 alignment key. To connect the cables to the PRO ECG Recorder: 1. Hold the PRO ECG Recorder in one hand; hold the Cable connector with your other hand.
  • Page 17: Connecting The Patient Cable To The Electrode

    CardioPerfect PRO ECG Recorder - User Manual Connecting the patient cable to the electrode Please refer to the table below for information on connecting the patient cable to the electrodes. Type of connection Connection to electrode Banana Alligator clamp Caution:...
  • Page 18 CardioPerfect PRO ECG Recorder - User Manual Clip DIR 80012763 Ver. H 18 / 25...
  • Page 19: Maintenance

    Clean the PRO ECG Recorder Unless the PRO ECG Recorder (the device itself rather than the cables and electrodes) comes in direct contact with a patient, it is acceptable to clean the device on a routine basis according to your facility's protocols and standards or local regulations.
  • Page 20: Clean The Cables

    PC USB interface cable. 2. Dry all cables with a clean, soft cloth or paper towel. 3. Wait at least 10 minutes before powering on the PRO ECG Recorder again. Disinfect the cables When disinfection is required, use chemical disinfectants containing ethanol (70%–80%), propanol (70%–80%), or aldehydes (2%–4%).
  • Page 21: Technical Specifications

    CardioPerfect PRO ECG Recorder - User Manual 4. Technical Specifications Table 2 CardioPerfect PRO Cardiograph PRO CARDIOGRAPH SPECIFICATION SE-PRO-600 Signal bandwidth 0.05 to 150Hz Sampling Rate 600 samples/sec SE-PRO-1200 Signal bandwidth 0.05 to 250Hz Sampling Rate 1200 samples/sec Internal Sampling Rate...
  • Page 22: Guidance And Manufacturer's Declarations

    Electromagnetic Emissions The Welch Allyn CardioPerfect PRO Cardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn CardioPerfect PRO Cardiograph should assure that it is used in such an environment.
  • Page 23 Electromagnetic Immunity The Welch Allyn CardioPerfect PRO Cardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn CardioPerfect PRO Cardiograph should assure that it is used in such an environment.
  • Page 24 Electromagnetic Immunity The Welch Allyn CardioPerfect PRO Cardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn CardioPerfect PRO Cardiograph should assure that it is used in such an environment.
  • Page 25 Welch Allyn CardioPerfect PRO Cardiograph The Welch Allyn CardioPerfect PRO Cardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Welch Allyn CardioPerfect PRO...

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