NorthEast Monitoring DR400 User manual

Part number: NEMM048-Rev-E

Revision: September 9, 2020

DR400 User Manual

patch style Holter recorder

with event capabilities

DR400 v5.07

PCPatch v1.06

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 2 of 20

Table of Contents

DR400 User Manual 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 ... 5

Patient Leads ... 5

Storage Capacity ... 5

Warranty Repairs ... 6

Operating the Recorder ... 6

Online help ... 6

Getting Started ... 6

Chapter 2 - Recording ECG ... 7

Step 1: Fully charge the DR400 ... 7

Step 2: Start the PCPatch utility ... 7

Step 3: Prepare patient ... 7

Step 4: Hook up Patient ... 8

Step 5: Start Recording ... 8

Step 6: Copy Holter file ... 9

Chapter 3 - The PCPatch Utility ... 10

DR400 Settings ... 11

To View Live Patient ECG ... 12

Technical Considerations ... 13

Wireless Event Recording ... 14

Chapter 4 - Appendices ... 15

Appendix A: Maintenance and Care of the Recorder ... 15

Appendix B: Pacemaker Detection ... 15

Appendix C: Accessories ... 16

Appendix D: Extraction of ECG data on 3-channel ... 16

Appendix E: EMC Information ... 17

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 3 of 20

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 recording is complete, Holter data is uploaded to a compatible version of

NorthEast Monitoring’s Holter Analysis software. For Holter, the DR400 recorder is compatible

with 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.

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: 34 grams (1.2 oz.) with battery

Electrical Specifications

The DR400 recorder 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.

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 4 of 20

DR400 User Manual About the DR400: Intended Use

Environmental Specifications

This equipment is not suitable for use in the pres-

ence 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 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 device in suf-

ficient quantities to interfere with satisfactory

operation. Water jets will not have harmful effect.

Wireless Specifications

The DR400 recorder is equipped with a wireless

Bluetooth transmitter. The Bluetooth specifica-

tions 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 event recorder module is a

patient activated device designed to record and

for diagnostic evaluation of transient symp-

toms (such as dizziness, palpitations, syncope,

and chest pain).

Indications for Use

1. Detection of Arrhythmias: The DR400

recorder is indicated for use in continuous

monitoring of cardiac rhythm when intermit-

tent arrhythmia are suspected due to patient

symptoms such as palpitations, transient isch-

emic 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 fre-

quency and duration of the arrhythmia com-

pared 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 USB cable that attaches to

any USB charging source (power plug) for

recharging. The battery will take at most, 2 hours

to fully recharge between uses.

Warning: A UL 60950-1 certified charger is

recommended for use with the recorder. A non-

certified charger may not be safe to use.

LED Display

The DR400 recorder has an LED display which

consists of a single light that indicates various

modes and conditions.

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 5 of 20

DR400 User Manual About the DR400: Warning Symbols

Warning Symbols

Please note that the recorder is labeled with the fol-

lowing warning symbols:

Refer to instruction manual/

booklet. Follow instructions for

use

Type BF device.

This device contains an internal

lithium battery that may be recy-

cled at end of life. This device

and all other accessories should

be disposed of according to local

ordinances.

This product does not contain

lead.

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.

Instructions to the User About

Electrical Interference

This equipment has been tested and found to com-

ply with the limits for a Class-B digital device, pur-

suant 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 manufac-

turer could void the user’s authority to operate this

equipment.

Patient Leads

The DR400 recorder is used exclusively with

NorthEast Monitoring patch electrodes which are

available in 1- and 3-lead configurations.

Storage Capacity

The patient’s ECG data is stored on non-volatile

memory internal to the recorder. The internal mem-

ory can store up to 470 MB of data.

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 6 of 20

DR400 User Manual About the DR400: Warranty Repairs

Warranty Repairs

The warranty for NorthEast Monitoring products

can be found on our web-site 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 Monitor-

ing will refuse delivery. The usable life of the

device and accessories are at least long as the war-

ranty 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 immediately

and contact NorthEast Monitoring or your dealer.

Warning: The recorder cannot be serviced while

in use on patient.

The DR400 recorder contains no user-service-

able parts. Removing the label or opening the

recorder voids the warranty.

NorthEast Monitoring can be contacted at: [+1]978-

461-3992, 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 press the EVENT button 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 leads could become entan-

gled 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 web site,

www.nemon.com or by emailing technical support

at [email protected].

The DR400 Technical Support page on the web-site

includes Frequently Asked Questions. The most

current version of manuals, the warranty and our

software can also be found on our web-site on the

“Downloads & Documents” page.

Getting Started

The DR400 recorder comes with a Quick Start

Guide, a USB cable and power plug, and a reusable

patient lead. A supply of disposable electrodes may

also have been included with your recorder.

Before recording, you should

charge your DR400 and download

and install the PCPatch utility.

More information about installing

and using the PCPatch utility can

be found in Chapter 3 and on the

DR400 Quick Start Guide.

The PCPatch utility download, a copy of the current

manual, the DR400 Quick Start Guide and technical

support can be found at www.nemon.com.

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 7 of 20

Chapter 2 -Recording ECG

The DR400 recorder has an internal battery and memory. Battery charging is done via a USB cable

attached to the power plug. The NorthEast Monitoring PCPatch Utility is used to update settings and

download data. In order to do this, the DR400 will be attached to the PC using a USB cable.

Step 1: Fully charge the DR400

You must fully charge your recorder before its first use. To charge the internal lithium battery, plug

the DR400 recorder into a USB charger (not a PC). While charging, the DR400’s LED light will flash

orange. Once fully charged, the LED light will flash green every 5 seconds. At this point, detach the

DR400 from the charger, and the recorder will stop flashing and go into standby mode.

It takes 2 hours to fully charge the battery from having no charge. A fully charged battery will record

Holter for up to 30 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 Event recording, the

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.

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 about downloading, installing

and using the PCPatch utility with your DR400.

After charging, but before starting a new recording, plug one end of the USB cable into the DR400 and

the other into the PC. Start the PCPatch utility and:

1. ERASE any data on the DR400. This will also update date and time.

2. Enter the NEW Patient ID for the next recording.

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 3 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

a ECG lead wire (3CH) or a 3-lead patch (3CH)

2. Determine the best location to attach the electrode patch and optional lead wire onto the patient, but

do not attach at this time.

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.

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 8 of 20

DR400 User Manual Recording ECG: Step 4: Hook up Patient

Step 4: Hook up Patient

1. Test the DR400 to ensure it is ready for the

next patient. Do this by removing the DR400

from the USB cable, wait for the flashing to

stop, and then quickly pressing the EVENT but-

ton. 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.

If you have one, you should insert a USB plug at

this time.

2. Attach electrodes to DR400. If using the 1-lead

electrode patch, attach the patch to the DR400.

If you are using the optional lead wire, attach it

to the patch now. Press down firmly so that all

snaps are locked in place.

3. Attach DR400 to Patient. Once the electrode

patch and optional patient extension lead wire

are attached to the DR400, remove paper back-

ing from electrodes and press firmly on to

patient to attach. Once the patch is in place,

attach an electrode to the extension lead wire

and attach to the patient in the proper location.

4. 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.

Step 5: Start Recording

1. To start the DR400 recorder, hold the “EVENT”

button down firmly until the green light goes

off. At the beginning of a new procedure, the

DR400 first shows a solid green light 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 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.

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 EVENT

button to indicate symptomatic events or activi-

ties of interest during the Holter test. Advise

them to push the EVENT button briefly.

4. Provide the patient with instructions on how to

use and change the patch and electrode for

patient extension lead wire.

1-lead electrode patch with

optional lead wire (3CH)

3-lead patch placement

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 9 of 20

DR400 User Manual Recording ECG: Step 6: Copy Holter file

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 to charge the DR400 about every 7

days. Let the patient know that the DR400 will flash

orange while charging, and then flash green when

fully charged.

When the recorder is in Event mode, the recording

will restart if the DR400 is erased or the recorder has

been plugged in for > 48 hours.

More information on Event Settings and pairing the

DR400 with the Gateway can be found in the next

Chapter.

Step 6: Copy Holter file

1. After recording is finished and the patch and lead

wire have been removed from the DR400, plug the

recorder into the USB cable that is attached to the

PC where the PCPatch utility is installed.

Note: For Holter, recording stops once the

DR400 is plugged into the USB cable for 2 min-

utes.

2. Start the PCPatch utility and copy the flash.dat file

(ECG data file). When doing a copy, the utility

will automatically find the next open patient direc-

tory in HE/LX Analysis.

3. Once copied, you may want to erase the file from

the recorder.

4. Remove the DR400 from the PC USB. At this

point plug the DR400 into a power source to

recharge the battery for its next use.

NorthEast Monitoring, Inc. NEMM048-Rev-E Page 10 of 20

Chapter 3 -The PCPatch Utility

The DR400 uses the PCPatch utility to save ECG patient data to HE/LX Anal-

ysis, enter patient IDs, and update settings on the recorder. The utility can also

be used to view your patients ECG data live via a Bluetooth USB that is

attached to the computer.

Download and Install the utility

Go to the NorthEast Monitoring web-site at www.nemon.com to download the PCPatch utility.

Select either the “Analysis” or “Remote” version, based upon your application.

Once downloaded, install the PCPatch on the computer where the HE/LX Analysis or LX

Remote software resides. The default directory, “c:\nm\bin” or “c”\nm\Remote” is where the

PCPatch utility will be installed, unless you specify otherwise. If your HE/LX Analysis or LX

remote software is located in a different directory, you will need to override the “nm” directory

at install. 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 the recorder shows a solid green

light, it is ready to communicate with the

PC. When the PCPatch is running will see

the main screen., and when the 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 - When recording com-

plete, save the patient file to the patient

directory. The PCPatch will automati-

cally select the next empty patient direc-

tory to save the file to.

•Erase DR400 - After the patient file is

saved, use this to erase the patient file from the recorder. You will need to do this before you

can start a new recording

•New Patient - After erasing previous patient, enter the Patient ID for the next recording

•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.

PCPatch main screen with Bluetooth available

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