NorthEast Monitoring DR400 User Manual

NorthEast Monitoring DR400 User Manual

Patch style holter recorder with event capabilities
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DR400 User Manual
patch style Holter recorder
with event capabilities
DR400 v5.07
PCPatch v1.06
Part number: NEMM048-Rev-E
Revision: September 9, 2020
Copyright 2020
All rights reserved

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Summary of Contents for NorthEast Monitoring DR400

  • Page 1 DR400 User Manual patch style Holter recorder with event capabilities DR400 v5.07 PCPatch v1.06 Part number: NEMM048-Rev-E Revision: September 9, 2020 Copyright 2020 All rights reserved...
  • Page 2: Table Of Contents

    DR400 User Manual Table of Contents Table of Contents Chapter 1 - About the DR400 ... 3 Specifications ... 3 Intended Use ... 4 Indications for Use ... 4 Device Charging ... 4 LED Display ... 4 Warning Symbols ... 5 Instructions to the User About Electrical Interference ...
  • Page 3: Chapter 1 -About The Dr400

    5.2 or newer versions of HE/LX Analysis. For Event, data is sent wirelessly to a location where the LX Event software is used to analyze. The DR400 recorder wireless Event is compat- ible with LX Event version 2.11 or newer.
  • Page 4: Intended Use

    Wireless Specifications any USB charging source (power plug) for recharging. The battery will take at most, 2 hours The DR400 recorder is equipped with a wireless to fully recharge between uses. Bluetooth transmitter. The Bluetooth specifica- tions for the DR400 are: Warning: A UL 60950-1 certified charger is •...
  • Page 5: Warning Symbols

    Patient Leads stacked with other equipment should be avoided because it could result in improper operation. If The DR400 recorder is used exclusively with such use is necessary, this equipment and the NorthEast Monitoring patch electrodes which are other equipment should be observed to verify available in 1- and 3-lead configurations.
  • Page 6: Warranty Repairs

    Prior to returning a recorder, you must obtain a return merchandise authorization (RMA) number. The DR400 recorder comes with a Quick Start This RMA number must be visible on the outside of Guide, a USB cable and power plug, and a reusable the packing carton, otherwise, NorthEast Monitor- patient lead.
  • Page 7: Chapter 2 -Recording Ecg

    DR400 should be charged every 7 days. If the DR400 is used frequently, for example, not left in the charger for more than a day or two, it is fine to keep it plugged in between uses. If you use your DR400 less frequently, for example it might be left in the charger for more than a few days, it is best to remove the DR400 from the charger once full charged.
  • Page 8: Step 4: Hook Up Patient

    (3CH) Step 4: Hook up Patient Step 5: Start Recording Test the DR400 to ensure it is ready for the To start the DR400 recorder, hold the “EVENT” next patient. Do this by removing the DR400 button down firmly until the green light goes from the USB cable, wait for the flashing to off.
  • Page 9: Step 6: Copy Holter File

    When the recorder is in Event mode, the recording Start the PCPatch utility and copy the flash.dat file will restart if the DR400 is erased or the recorder has (ECG data file). When doing a copy, the utility been plugged in for > 48 hours.
  • Page 10: Chapter 3 -The Pcpatch Utility

    Settings - Update the Recorder settings and pair with Bluetooth and/or Gateway DR400 Date and Time. When the data on the DR400 is erased using the PCPatch utility, the date and time on the recorder will be updated to match the date and time on the PC. After eras- ing, you can view the date/time on the right-hand side of the PCPatch Settings screen.
  • Page 11: Dr400 Settings

    Post Event Seconds. Number of seconds saved after About the DR400 the event. Up to 240 seconds allowed. The following items are about the DR400 and cannot be Auto Detect Settings for Event updated via the PCPatch: Serial No. of DR400 recorder,...
  • Page 12: To View Live Patient Ecg

    The PCPatch Utility: To View Live Patient ECG Using PCPatch to View ECG To View Live Patient ECG With the DR400 ready to record and attached to the The DR400 transmits a Bluetooth signal for ECG patient, start the PCPatch application. Once the util- viewing.
  • Page 13: Technical Considerations

    LX Remote desktop application exists. The installation will default to the c:\nm\Remote direc- tory. Once the DR400 file is copied to the LX Remote directory, you should open the Patient Information window in LX Remote and enter the patient infor- mation before sending the file.
  • Page 14: Wireless Event Recording

    Event recording on the DR400 is done wirelessly, via a NorthEast Monitoring Gateway and the Once an event has been saved, the DR400 will Socket software. Refer to the Gateway - Socket attempt to contact the Gateway every 20 minutes Technical Manual, NEMM046, for more informa- for the first hour, and then once an hour after that.
  • Page 15: Chapter 4 -Appendices

    Sterilization is not needed. Do not submerge the recorder in water. At the end of their useful lives, all NorthEast Monitoring Inc. products should be disposed of following local ordinances. Appendix B: Pacemaker Detection The recorder has a built-in pacemaker detection capability. This was designed to overcome the problems inherent with the analysis of Holter recordings from patients with pacemakers.
  • Page 16: Appendix C: Accessories

    DR400 User Manual Appendices: Appendix C: Accessories At recording time, it is desirable to have the Appendix D: Extraction of recorder be as sensitive to the pacemaker pulse as ECG data on 3-channel possible so pulses will not be missed. A conflicting...
  • Page 17: Appendix E: Emc Information

    Guidance and manufacturer’s declaration – electromagnetic emissions The Northeast Monitoring DR400 Recorder is intended for use in the electromagnetic environment specified below. The customer or user of the Northeast Monitoring DR400 Digital Recorder should ensure that it is used in such an environment.
  • Page 18 Appendices: Appendix E: EMC Information Guidance and manufacturer’s declaration – electromagnetic immunity The Northeast Monitoring DR400 is intended for use in the electromagnetic environment specified below. The customer or user of the recorder should ensure that it is used in such an environment.
  • Page 19 Appendices: Appendix E: EMC Information Guidance and manufacturer’s declaration – electromagnetic immunity The Northeast Monitoring DR400 Recorder is intended for use in the electromagnetic environment specified below. The customer or user of the recorder should ensure that it is used in such an environment.
  • Page 20 Recommended separation distances between portable and mobile RF communications equipment and the Northeast Monitoring DR400 Digital Recorder The Northeast Monitoring DR400 Digital Recorder is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer of the user of the recorder can help...

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