NorthEast Monitoring DR400 Patch Style Holter Recorder with Event Capabilities User Manual

Holter Recorder with Event Capabilities
User Manual

Chapter 1 -About the DR400
The NorthEast Monitoring DR400 patch-style recorder can be used as either a Holter monitor and/or a looping Event recorder. Data obtained by monitoring is not analyzed at the time of recording. After the recording is complete, Holter data is uploaded to a compatible version of NorthEast Monitoring’s Holter Analysis software. The DR400 recorder is compatible with 5.2 or newer versions of HE/LX Analysis software. For Event, data is sent wirelessly to a location where versions 2.11 or newer of the LX Event utility is used to review and report on the recording. The DR400 Recorder is not intended to replace real- time telemetry monitoring for patients suspected of having life-threatening arrhythmias. The DR400 Recorder is not for In Vitro diagnostic use.

Specifications

Physical Specifications
The DR400 recorder meets the following physical specifications:

•  Size: 6.8 cm (length) x 3.9 cm (width) x 1.3 cm (depth)
• Weight: 33 grams (1.2 oz.) with battery

Electrical Specifications
The DR400 recorder’s electrical specifications are:

• Recording bandwidth: 0.05 to 70 hertz in 180 samples/sec. mode*

• Operation duty cycle: Continuous

• Data storage format: Sample difference

• Pacemaker sensitivity: 2 millivolts

• Pacemaker pulse duration: 150 to 2,500 microseconds

• Resettable fuses: 0.5 amp

• When measuring millivolts, results should be within 5% of expected results.
  Environmental Specifications
  This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The operating range of the device is between 10 and 45 degrees C, between 10 and 95% humidity, and between 500 and 1060 hPa pressure. Store and/or transport the recorder at temperatures between -20 and 60 degrees C for up to 1 month, and -20 to 30 degrees C for the long term; and between 10 and 95% relative humidity, and 500 and 1060 hPa pressure.
  IP44 Ingress Protection
  The DR400 recorder has an Ingress Protection Marking of IP44. Dust will not enter the device in sufficient quantities to interfere with satisfactory operation. Water jets will not have harmful effects.
  Wireless Specifications
  The DR400 recorder is equipped with a wireless Bluetooth transmitter. The Bluetooth specifications for the DR400 are:

  • Receive Sensitivity: 95 dBm
  • Output Power: 10.5 dBm max
  • Link Budget: Up to 105.5 dB
  • RX/TX Turnaround: 150 us
  • Frequency: 2402 – 2480 MHz in 1 Mhz steps
  • Data Rate and Modulation: BR:1 Mbps, GFSK / EDR: 2-3 Mbps PSK
  • Number of Channels: 79

Intended Use

• Holter Mode: Detection of Arrhythmias and efficacy of Pharmacological Treatment.
• Event Mode: The recorder captures events automatically or when activated by the patient for diagnostic evaluation of transient symptoms.

Indications for Use

1. Detection of Arrhythmias: The DR400 recorder is indicated for use in continuous monitoring of cardiac rhythm when intermittent arrhythmia is suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIAs), syncope (fainting), or other such symptoms as determined by the physician.
2. Efficacy of Treatment: DR400 recorder is indicated for use to determine whether current pharmacological treatment(s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.

Device Charging
The DR400 recorder has an internal rechargeable Lithium battery that is not user replaceable. The recorder comes with a Docking Station and USB cable that attaches to any  SB charging source (power adapter) or PC for recharging. The battery will take at most, 3 hours to fully recharge between uses.
Warning: A UL 60950-1 certified charger is recommended for use with the recorder. A noncertified charger may not be safe to use.
LED Display
The DR400 recorder has an LED display that consists of a single light that indicates various modes and conditions.
Patient Leads
The DR400 recorder is used exclusively with NorthEast Monitoring 1- or 3-lead patch electrodes or a 3-lead adapter.
Storage Capacity
The patient’s ECG data is stored on non-volatile memory internal to the recorder. The internal memory can store up to 470 MB of data.
Symbols
Please note that the recorder is labeled with the following symbols:

| Refer to the instruction manual/ booklet. Follow instructions for use
---|---
| Type BF device.
| This device contains an internal lithium battery that may be recycled at end of life. This device and all other accessories should be disposed of according to local ordinances.
PB| This product does not contain lead.
RXonly| Caution: Federal law restricts this device to sale by or on the order of a physician
| This device has Bluetooth capabilities.

Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
The Docking Station

The DR400 comes with a docking station that is used for recharging the battery, uploading Holter data, and updating the DR400. The docking station can be attached to either a PC for charging and data transfer, or a power adapter for charging only. A cable with a micro-USB connector attaches to the docking station, and the USB end of the cable connects to a PC or power adapter. Before or after a procedure, firmly attach the DR400 to the docking station via two electrode snaps. When attached via the snaps, a connection is made when the 4 small pads on the recorder come in contact with the 4 spring pins on the base of the docking station. Once the DR400 is attached to the docking station, the recorder will recharge automatically. Additionally, after 2 minutes, the DR400 will stop recording Holter data and end the procedure.
Instructions to the User About Electrical Interference 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Consult the dealer or an experienced radio/TV technician for help.

This equipment has been certified to comply with the limits for a Class-B computing device, pursuant to FCC Rules. In order to maintain compliance with FCC regulations, shielded cables must be used with this equipment. Operation with non-approved equipment or unshielded cables is likely to result in interference to radio and TV reception. The user is cautioned that changes and modifications made to the equipment without the approval of the manufacturer could void the user’s authority to operate this equipment.
Warranty Repairs
The warranty for NorthEast Monitoring products can be found on our website at www.nemon.com. Contact your dealer or NorthEast Monitoring prior to returning a recorder for repair to determine the warranty period, conditions, and exclusions. If your dealer is unavailable, contact NorthEast Monitoring directly. The recorder can only be serviced or repaired by NorthEast Monitoring or a NorthEast Monitoring authorized representative. Prior to returning a recorder, you must obtain a return merchandise authorization (RMA) number. This RMA number must be visible on the outside of the packing carton, otherwise, NorthEast Monitoring will refuse delivery. The usable life of the device and accessories are at least long as the warranty period.
Operating the Recorder
If you require training, such as assistance in setting up, using, or maintaining your recorder, contact NorthEast Monitoring or your dealer. Should the recorder fail to work properly during its useful life or changes its performance, stop using it immediately and contact NorthEast Monitoring or your dealer. Warning: The recorder cannot be serviced while in use on a patient.
The DR400 recorder contains no user-serviceable parts. Removing the label or opening the recorder voids the warranty.
NorthEast Monitoring can be contacted at: [+1]978461-3992, toll-free in the U.S.A. at 866-346-5837, or email [email protected].
The patient is not the primary operator but may be asked to use the PRESS button to record or transmit events. Care should be taken when this device is used, especially with infants or small children, as it includes small internal parts that could be a choking hazard. Additionally, the lead could become entangled and could be a strangulation hazard.
Online help
In addition to the information in this manual, more information and help can be found at our website, www.nemon.com, or by emailing technical support at [email protected].
The DR400 Technical Support page on the website includes Frequently Asked Questions. The most current version of manuals, the warranty, and our software can also be found on our website on the “Downloads & Documents” page.
Chapter 2 -Recording ECG
Step 1: Fully charge the DR400 You must fully charge your recorder before its first and every use. To charge the internal lithium battery, place the battery into the docking station, and with the USB cable attached, plug the cable into the power adapter. When plugged in, the DR400 will flash orange while charging, and once fully charged, will flash green every 5 seconds. At this point, you can remove the DR400 from the docking station, and the recorder will stop flashing and go into standby mode. It takes approximately 2 hours to fully charge the battery from having no charge. A fully charged battery will record Holter for up to 14 days, but we highly recommend that you charge the DR400 between patients. For 24-hour recordings, this will take only about 10 minutes between recordings. For long Event recordings, the DR400 should be charged every 14 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 plugged in for more than a few days, it is best to remove the DR400 from the charger once fully charged. You will then want to plug it in again to ensure it is fully charged before your next study, but that should only take a few minutes.
Step 2: Start the PCPatch utility
See chapter 3, The PCPatch Utility, for more information on using the PC Patch.
Place the fully charged DR400 into the docking station and attach the docking station to the
PC using the USB cable. Start the PCPatch utility and:

1. ERASE any data on the DR400. This will also update the date and time.
2. Enter a New Patient ID for the next recording.
3. For DR400 v5.22 and greater, you can now click on the Start DR400 button in the PCPatch window. If started, you will see a message that the DR400 will start once removed from the docking station. If you see a message “THIS DR400 CANNOT BE STARTED VIA THIS BUTTON,” you will need to start the recorder as described in Step 4: Hook up Patient.

Step 3: Prepare patient
Patient preparation and patch placement is critical to obtain a quality ECG signal. To ensure proper hook-up, follow these steps:

1. There are four hook-up options for the DR400: Select either a 1-lead electrode patch (1CH) for event or Holter, a 1-lead electrode with the addition of an ECG lead wire (3CH), a 3-lead patch (3CH) or the reusable 3-lead adapter.
2. Determine the best location to attach the electrode patch and/or electrodes.
3. Prepare the patient’s skin. If the patient has hair in any of the site, shave it with a safety razor. Use an alcohol pad and rub the sites briskly until the skin reddens. For best patch adhesion, allow the skin air dry before proceeding.

Step 4: Hook up Patient

1. PCPatch Utility. If you want to observe lead quality at hook-up, start the PCPatch utility if not already running. Once the PCPatch utility finds the Bluetooth USB and is “waiting for DR400”, the utility is ready for you to start the DR400 recorder.
2. Remove the DR400 from the docking station. If the DR400 was started via the PCPatch, jump to Step 3.
3. To otherwise start the DR400, press and hold the DR400 button down until the green light starts flashing. If the light immediately turns orange, this means one of two things: 1) the previous patient’s data has not been erased or 2) it has been erased and there is no new Patient ID. You will need to plug the recorder back into the USB and use the PCPatch utility to delete the file and/or enter a new Patient ID.
4. Attach electrodes to DR400. Attach the patch or adapter to the DR400. If you are using the optional lead wire with the 1-lead patch, attach it now. Press down firmly so that all snaps are locked in place. The 3-lead adapter lanyard should be placed around the patient’s neck.
5. Attach Patch to Patient. Remove paper backing from the patch and press firmly onto the patient to attach. If using an optional lead wire with the patch, attach an electrode to the extension on the lead wire and attach to the patient in the proper location. For the 3-lead adapter. Attach electrodes to each lead and adhere electrodes as pictured in the example.

Step 5: Start Recording

1. To start the DR400 recorder, hold the PRESS button down firmly until the green light goes off. At the beginning of a new procedure, the DR400 first shows a solid green lithe ght which goes off when recording has started. You can tell it has started when:
   • The DR400 will flashes green for 30 seconds (v5.04) or up to 60 minutes (v5.06).
   • If the PCPatch is on and the DR400 has been paired with the local Bluetooth, the ECG viewer will automatically open and you will be able to view the ECG. Once the viewer window is closed, the DR400 will continue to record but will stop flashing at this time. Warning: If the light on the DR400 turns a solid orange, this means that the previous patient’s data is still on the DR400 or the DR400 does not have a Patient ID. When this occurs, you must plug the DR400 into the PC and use the PCPatch utility to save and/or delete the previous patient’s data and/or enter a new Patient ID.

2. Advise the patient that showering is allowed with the DR400 and patch attached, but we do not recommend that the patient go swimming or bathing while wearing either.

3. Instruct the patient on how to use the PRESS button to indicate symptomatic events or activities of interest during the Holter test. Advise them to push the PRESS button briefly.

4. Provide the patient with instructions on how to use and change the patch or electrodes.

Wireless Event

For Event recording, the patient must also be sent home with a NorthEast Monitoring Gateway that is set up to transmit events wirelessly and a USB charger with instructions o charge the DR400 every 14 days if required. Let the patient know that the DR400 will flash orange while charging, and then flash green when fully charged. When the order is in Event mode, the recording will stop if the DR400 is erased or the recorder has been plugged in for > 48 hours.
Step 6: Copy the Holter file

1.  After the recording is finished and the patch and lead wire have been removed from the DR400, plug the recorder into the docking station that is attached to the PC where the HE/LX Analysis or LX Remote software is installed.
   Note: For Holter, recording stops once the DR400 is plugged into the PC or powered for 2 or more minutes.

2. Copy the flash.dat file (ECG data file) into the next available patient directory and analyze or send the file as usual.

Chapter 3 -PCPatch & Wireless
The PCPatch utility is used to set up and start the DR400 for each procedure. From the utility, you can copy the Holter file, erase data, preview he file, update settings and enter the Patient ID. Optionally, the utility can also be used to view your patient’s ECG data live via a Bluetooth USB that is attached to your PC.
Download and Install the utility
Go to the NorthEast Monitoring website at www.nemon.com to download the PCPatch utility. Once downloaded, install the PCPatch on the computer where you prepare the DR400s for the next procedure. The default directory, “c:\nm\bin” is where the PCPatch utility will be installed, unless you specify otherwise. If HE/LX Analysis or LX Remote is located in a different directory, you will need to override the “nm” directory at installation. Once installed, you should see a shortcut on your desktop. Click on the shortcut to run the PCPatch utility.
Using the PC Patch Utility
Plug the DR400 into the USB on the same PC where the PCPatch utility is running. When a DR400 is found, you can do the following:

•  Preview – When a patient file is on the DR400, you can view the Recorder S/N, the Patient ID, and the date and start time of the recording
• Copy Flash.dat – Although this button can be used to copy the flash.dat file into the next open directory in HE/LX software, we recommend that you use the HE/LX or LX Remote copy feature to upload the file when the procedure is complete.
• Erase DR400 – After the patient file is saved, use this to erase the patient file PCPatch main screen with Bluetooth available from the recorder. You will need to do this before you can start a new recording. You will also need to erase the previous file before you can update the settings for your next recording.
• New Patient – After erasing the previous patient, enter the Patient ID for the next recording
• Settings – Update the Recorder settings and pair with Bluetooth and/or Gateway. The DR400 must be erased before Settings can be updated.
• Start DR400 – For DR400 versions 5.22 and greater, this button can be used to start the recorder. The DR400 must be erased and have new Patient ID number to be started.

DR400 Settings
DR400 settings are updated via the Settings screen in PCPatch. Except for Pairing the DR400, the recorder must first be erased before Settings can be updated. Recorder Type. Holter will record up to 3-channels, and Event will record 1-channel. For Holter, the DR400 will record up to 14 days. Event Marker. When “On”, the ECG will be labeled with one second of a 6-cycle square wave at the event. Event Settings Are enabled when Recorder Type  Event. Pre- Event Seconds. A number of seconds saved before an event is detected. Up to 60seconds allowed. Post Event Seconds. A number of seconds saved after the event. Up to 60 seconds allowed. Auto Detect Settings for Event Auto Detect Turn auto detection On/Off for all event types, including AF. AF Detect. Turn Atrial Fibrillation detection On/Off. Minimum Time Between AF. For AF events only. The range of 2 – 90 minutes.
Minimum Peak AF HR. Minimum HR that at least 3 beats of the previous 20 must exceed, in order for an event to be called AF. The range is 60 – 120 BPM.
Brady Limit If a heart rate on or below this number is detected, a Brady event will be recorded. The range is 20 – 100 BPM. Tachy Limit. If a heart rate on or above this number is detected, a tachy event will be recorded. The range is 50 – 300 BPM. Pause Limit. If no heartbeat is detected for at least the pause length in seconds, a pause event will be recorded. The range is 1.0 to 10.0 seconds. Separation. Limits the number of events by type by requiring a minimum amount of time between the same type of event. Applies to all events, except AF. The range is 2 – 60 minutes. Update Recorder and Close. Click to save changes. Close the window to make no changes. MCT Check Time. When ETel-MCT is being used, how frequently the DR400 will check the FTP site for instructions? The options range from 20 to 240 minutes. When set to OFF, the recorder will not check for ETel messages, however, if a message exists when an event is being transmitted, the message will be received and the DR400 will respond accordingly.
About the DR400
The following items are about the DR400 and cannot be updated via the PCPatch: Serial No. of DR400 recorder, CC (Customer Code), the Version number of firmware on DR400, and Build number of firmware on DR400 Date and Time. The current date and time are automatically updated when the DR400 is erased using the PCPatch utility.

**To View Live Patient ECG

**

The DR400 transmits a Bluetooth signal for ECG viewing. When the PCPatch is running and receives the Bluetooth signal, it will open an ECG Viewer screen. You must have the Bluetooth USB adapter pictured below to view the patient’s ECG on the PC.

First, install Bluetooth USB
Plug the Bluetooth USB into the same PC where the PCPatch utility is installed. It may take a short time for the Bluetooth USB driver to be installed onto the PC. Once installed and functional, the mode button on the Bluetooth USB will flash green.
Second, start the PCPatch utility. Upon starting the PCPatch, you will first see “Looking for BT” while the utility searches for a Bluetooth USB that is physically attached to the PC. When the PCPatch Utility is running and the Bluetooth USB is found and ready to receive a signal, you will see the message, “Waiting for DR400”.
Note: The PCPatch utility only searches for the Bluetooth USB at start up or while attempting to pair with a DR400. If not found, close PCPatch and restart again.
Third, pair the DR400 to Bluetooth USB. Before you can view live ECG with a particular DR400, you will first need to pair the DR400 with your Bluetooth USB. On the PC where the Bluetooth USB is installed, plug in the DR400, open the PCPatch and go to the Settings screen. Click on the “Pair Bluetooth USB”

and the PCPatch will attempt to pair the two. Once paired, you will see the USB number on the Settings screen. The last 5 numbers should match the Serial Number of your Bluetooth USB. The button is only enabled when a Bluetooth USB was found when the PCPatch utility started.
Using PCPatch to View ECG
With the DR400 ready to record and attached to the patient, start the PCPatch application. Once the utility shows “Waiting for DR400”, hold the PRESS button down to start the recording. Once the green light turns from solid to flashing, the recording has begun and transmits Bluetooth for about 15 seconds. After a brief pause, the PCPatch utility should open the window to view ECG.

If recording has already started and you wish to view the ECG, hold the button down until it starts flashing green rapidly, and then release.

Troubleshooting

No Bluetooth “No BT” message:

• If the Bluetooth USB is installed on the same computer, and the PCPatch fails to see it, you can try to restart the PCPatch so that it searches again. The PCPatch only searches for the Bluetooth USB at start-up.
• Unplug and reinsert Bluetooth USB. Check to make sure that the mode light is flashing green. Restart the PCPatch utility to restart the search.
• Drivers for the Bluetooth USB were included with your Windows Operating System. But if you plug in the Bluetooth USB for the first time and the PC is unable to see it at all (the mode light on the USB is not flashing green), you may need to locate and reinstall the device drivers.

“Waiting for DR400” message: If you see this message and the DR400 appears to be transmitting but you have no ECG screen, perhaps the DR400 is not paired with the Bluetooth USB that is plugged into the PC. If you want to fix this now, you will need to remove the DR400 from the patch electrode and plug it into the USB cable to pair it with the Bluetooth USB from the Settings screen.
Wireless Event Recording
Event recording on the DR400 is done wirelessly, via a NorthEast Monitoring Gateway and an FTP site. Refer to the Gateway – FTP Technical Manual, NEMM046, for more information on how to set up and run the Wireless feature.
The Gateway Settings
The Gateway field on the Settings screen shows which Gateway has been paired with the DR400.

The Service URL key, Remote Server URL, Remote Server Port,  Carrier APN, and Key ID are all required to transmit successfully.
If any of these items are blank or incorrect, you can update these by putting your URLKEY.dat file into the bin directory and pairing the Gateway again. If your URLKEYdat is incorrect or you do not have a URLKEYdat file, contact NorthEast Monitoring or your distributor for assistance.
Important: A URLKEY.dat file must exist in your directory in order to pair with a new Gateway. If the file does not exist, the Pair Gateway button will not be enabled. Recording an Event
Procedure Event recording is for channel 1 only, but otherwise, the setup and recording procedure are the same as Holter and are described in the previous chapter. While recording in Event mode, the patient should charge the DR400 every 14 days at a minimum. Remind the patient that the recorder will flash orange while charging, and then flash green when fully charged. As with Holter, the patient can record an event by pressing the PRESS button quickly. The recorder will flash green when recording an event. Flashing will also occur when the recorder is saving an automatically generated event.
Transmitting Events
Once an event has been saved, the DR400 will attempt to transmit by contacting the Gateway after 20 minutes. After several tries, and if a Gateway is not found or wireless transmission is not successful, the recorder will then try every two hours to make a connection. Once a transmission is successful, the DR400 will attempt to send events until all are sent. Transmitting Events Manually With the Gateway present and receiving a good signal, hold the PRESS button down until the DR400 starts flashing orange rapidly. At this point, the DR400 will attempt to connect with its paired Gateway in order to send transmissions. This can be done during or after the procedure has stopped.
Events on returned DR400

After the event procedure, the Settings screen will show you the total number of events that were saved as well as any that are still remaining and not transmitted. If you would like to save the remaining events, you will need to plug in the Gateway and transmit the events manually as described above.
ETel – Mobile Cardiac Telemetry (MCT) monitoring
NorthEast Monitoring’s ETel utility must be installed on your PC for Mobile Cardiac Telemetry (MCT). MCT is a feature that can be added to a  DR400 in the Event recording mode and allows for bidirectional communication between the PC and the DR400 without patient interaction. MCT allows you to request continuous recording for a period of time within the past 72 hours and also allows you to change any or all of the Auto Detect Settings during the event procedure.
The ETel Utility The ETel utility is used to send MCT messages to the DR400 during the procedure. The screen below shows a request that would be used to obtain ECG data. ECG data requests must be within the last 72 hours. Up to 10 minutes at a time can be requested. Multiple requests can be sent during a single procedure, however, only one request at a time can be queued for a single DR400.

Additionally, Auto-event settings can be updated during the procedure. The values for the next setting are put in the New Setting Value field.

Once a request is Sent, it will be queued in the window on the right. For each DR400, only one request can be sent at a time. The request will be removed from the list once it has been received by DR400. In this example, the mct file type is for requesting time, and the mcs file type is for changing the settings. If you need to delete command before it is sent, you can click on it while on the list and confirm that you want it removed.

DR400 Settings
The DR400 will return its settings to view after it receives an MCT command and that file will be a file type set. The file 109197.set will show the recorder settings when clicked on. The set file will be updated if a new MCT command is sent and will be removed from the list after 72 hours.
Chapter 4 -Appendices
Appendix A: Maintenance and Care of the Recorder Clean the outside of the recorder with a damp soft cloth between uses; use water and non-abrasive liquid soap, as required.
DO NOT use any abrasive cleaners, such as acetone, on the outside of the recorder.  Disinfect as needed, following instructions from your infection control department. Sani-Cloth germicidal surface wipes are recommended. 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. A pacemaker is designed to initiate cardiac conduction by stimulating a spot on the myocardium with a pulse of 1-4 volts and a duration of typically 250 to 2,000 microseconds.
When this pulse is seen at the surface recording electrodes it is significantly attenuated. For patients with a unipolar electrode configuration, the signal at the surface may range from under 50 to over 200 millivolts. When a bipolar lead configuration is used, the signal is typically much lower and is in the range of 3 to 50 millivolts. Especially with the bipolar leads, the signal size is dependent on the positions of the pacemaker lead and the surface electrodes. The amplitude of the signal being referred to here is not the size of the “spike” commonly seen on an ECG cart or bedside monitor. Since the duration of the pulse is short compared to a QRS complex, normal ECG recorders will greatly attenuate the signal; in some cases, it cannot be seen at all. Also, some ECG recorders have devices that enhance the pacing pulse to insure that it will be displayed. Only very wide bandwidth recorders as are sometimes used in an electro-physiology study will show the unmodified full amplitude of the pulse. The recorder has the wide bandwidth ECG amplifiers necessary to pass the pacemaker pulse. Since the pulse would still be too short to be recorded in a reliable manner at any practical sampling rate for Holter recording, the pulse is detected by the recorder. The time of the pulse is then digitally stored along with the Holter ECG data. When the data is analyzed, the pacemaker pulse is displayed and used for the analysis.At recording time, it is desirable to have the recorder be as sensitive to the pacemaker pulse as possible so pulses will not be missed. A conflicting requirement is that there should be as few false pacemaker detections as possible. False pacemaker detections are primarily caused by electrical events. Any external electrical signal that is coupled to the patient electrodes which looks like a pacemaker pulse will of necessity be stored by the recorder. The most common form of electrical signal that can look like a pacemaker signal is an electrostatic discharge (ESD) or “spark.” These happen very frequently in dry weather but also occur, at a lower rate, under humid conditions.
Fortunately, most ESD spikes as seen at the patient electrodes are of shorter duration or of lower amplitude than the real pacemaker pulses. While there is no absolute limit to the size or duration of the ESD pulses, the recorder ignores all pulses that are less than 150 microseconds long or are less than two millivolts in size. As pacemakers are normally programmed to a pulse width greater than 200 microseconds, this does not cause a loss of detection. The requirement that the pacemaker pulse be at least two millivolts in size is not a common problem.
Appendix C: Accessories
Contact your distributor to purchase accessories for the DR400.
NEMEL002. 1-lead electrode patch
NEMEL003. 3-lead electrode patch
NEMCA161. 16” Reusable patient extension lead wire (use with NEMEL002 for 3-channel)
NEMCA162. 3-lead adapter cable with lanyard
NEMH238. Lanyard for 3-lead adapter
NEMH226. DR400 docking station.
NEMP00511. USB Power Port Adapter LV Sun with 3’ power cord.
NEMP00513. Sena Parani Mfg PN SD1000U: Bluetooth USB Adapter for Serial Port
Appendix D: Extraction of ECG data on 3-channel
It is possible to retrieve the raw ECG files from the Holter files. For all 3-channel data, the process results in three files, one for each channel. Each file is then in the form of a binary file consisting of 16bit words (little endian) with each word representing one sample. The sampling is at 180 samples per second. The data is scaled so that the least significant bit has a value of 12.5 UV. If a pacemaker pulse was detected, the sample at the time of detection will be replaced by the value 0x8000.
To gen, and rate these files, first analyze the data (actually the flash.dat) from the recorder using any compatible version of the LX Analysis program. A,t the completion of this there will be a file “datacard.dat” in the patient directory. The full path is by default: c:[nm\pat\xx\datacard.dat](http://nm%5Cpat%5Cxx%5Cdatacard.dat)
where xx is the number of the patient dataset.
This can be seen in the “No. and Directory” columns of the
“File->open/new” display.
Then, change the directory to c:\nm\bin and on a  single command line, run the following command  using the following 5 arguments: unpacked d1 f1 f2 f3 0

• where d1 is the path to the source Datacard file, for example,
  d1= c:\nm\pat\xx\datacard.at

• f1, f2, and f3 are the resultant binary destination
  files, for example:
  f1 = c:\nm\pat\xx\flashc0.dat
  f2 = c:\nm\pat\xx\flashc1.dat
  f3 = c:\nm\pat\xx\flashc2.dat

The result will be the three files in the patient directory xx described previously. The files are flashc0.dat flashc1.dat and flashc2.dat which are for channels 1,2 and 3 respectively. If desired, the destination paths for this command can be any other path but spaces are not allowed in the path or file name.
Appendix E: Technical Considerations
LX Remote Installations You may want to install the PCPatch Utility on the PC where the LX Remote desktop application exists. Use the PCPatch to erase, update and prepare the DR400 for your next patient, however, you should only use the LX Remote software to copy the file off of the DR400 when the procedure is complete.
Network Installations
For Holter, if the PCPatch utility is being installed on a PC that does not have HE/LX Analysis installed, you will need to do the following to allow the user to save patient files to HE/LX Analysis:

1. Ensure that the local PC has read/write access to the HE/LX Analysis patient directory on the server
2. . On the local PC, create a directory labeled “c:\nm\bin”  Copy the h4w.ini file from a PC that has HE/LX Analysis installed and paste it into the local directory. (The h4w.ini file most likely can be found in the c:\nm\bin directory.

Using Windows, test to ensure that the path to the Patient Directory works for the PC where PCPatch is installed. Microsoft File Explorer keeps opening when DR400 is plugged in

If the window keeps opening, it may be that your connection is loose. But if you want to prevent the window from opening
when you first plug in or erase your DR400, you can adjust your Windows Settings. Go to Settings > Devices >AutoPlay and for Removable Devices,  set it to “Take no action”.

Appendix F: EMC Information Attention should be paid to the following EMC information prior to installing or using the Northeast Monitoring DR400 Recorder device.

• Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of the device.
• The device has been tested and found to comply with IEC/EN 60601-1-2.
• Computers, cables, and accessories not tested to 60601-1-2 may result in increased emissions or decreased immunity of the device.
• Verify normal operation if utilizing the device adjacent to or stacked with other electrical equipment.

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.
Emissions Test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| Northeast Monitoring DR400 Digital Recorder uses RF energy only for its internal function. Therefore, its RF emissions are not likely to cause any in nearby electronic equipment.
RF emissions CISPR 11| Class B| Northeast Monitoring DR400 Digital Recorder is suitable for use in all establishments other than domestic and those direct connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage Fluctuations/flicker emissions IEC 61000-3| Not applicable
Guidance and manufacturers 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.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment — guidance
Electrostatic discharge (ESD) IEC 61000-4-2| t 6kV contact t 8kV air| t 6kV contact t 8kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4| t 2 kV for power supply lines t 1 V for input/ output lines| Not applicable. No cables exceed 3 meters| The main power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| t 1 kV line(s) to line(s) t 2 kV line(s) to earth| Not applicable. Northeast Monitoring DR400 Recorder is battery-powered.| N/A
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| < 5% UT (>95% dip in UT) For  ,5 cycle 40% UT (60% dip in UT)  or 5 cycles  70% UT  (30% dip in T) for 25 cycles < 5ok uT(>95% dip in UT) for 5s| Not applicable. Northeast Monitoring DR400 Recorder is battery- powered.| N/A
Power frequency (50/ 60 Hz) magnetic field IEC 61000-4-8| 3 Alm| 3 Alm| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment — guidance
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-| 3 Vrms 150 kHz to 80 MHz 3  /m  80 MHz to 2,5 GHz| 3 V 3 V/m| Portable and mobile communications equipment should be used no closer to any part of the Northeast Monitoring DR400 Recorder, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance d = 1.2 VP
d = 1.2 VP 80 MHz to 800 MHz
d = 2.3 VP 800 MHz to 2.5 GHz
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  transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.b Interference may ccur in the vicinity of equipment marked with the 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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the recorder is used exceeds the applicable RF compliance level above, the recorder should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or recorder
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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 prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the recorder as recommended below, according to the maximum output power of the communications equipment.
The rated maximum output power of the transmitter W| Separation distance according to the frequency of the transmitter m
150 KHz to 80 MHz d = 1.2 Ö P| 80 MHz to 800 MHz d = 1.2 Ö P| 800 MHz to 2.5 GHz d = 2.3 Ö P
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation 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.
NOTE 2:  These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

NorthEast Monitoring, Inc.
141 Parker Street, Suite 200 Maynard, MA 01754 USA
www.nemon.com
advancing Hotter technology
phone: (+1) 978-461-3992 fax: [+1] 978-461-5991 toll free USA: 866-346-5837
email: [email protected]
Pad number: NEMM048-Rev-H
Revision: January 24, 2022
Copyright 2022 All rights reserved

References

• Holter Monitor - Event Recorder | NorthEast Monitoring
• DR400 Recorder - Support | FAQs | NorthEast Monitoring

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