NorthEast Monitoring DR200/HE, DR300 Owner's Manual

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DR200/HE and DR300

Digital Holter/Event Recorder

Operator’s Manual

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DR200/HE & DR300 Operator’s Manual Table of Contents

Table of Contents

Chapter 1 - Introduction...3

Specifications...3 Intended Use...4 Indications for Use...4 Warning Symbols...5 LCD Display...5 Instructions to the User About Electrical Interference...5 Patient Leads...6 Storage Capacity...6 Warranty Repairs...6 Operating the Recorder...7 Online help...7 Wireless Bluetooth (DR300 only)...7

Chapter 2 - Holter Recording...8

The Holter Recording Procedure...8 Power Loss Protection Feature...12

Chapter 3 - Event Recording...13

The Event Recording Procedure...13 To Transmit or Save Events...15 Event Recording: Patient Operating Instructions...17

Chapter 4 - Recorder Settings, Error Messages and Troubleshooting...19

Error Messages and Troubleshooting...22

Chapter 5 - DR300 Tablet App...23

To Update Settings on DR300 Recorder...24 Live ECG Viewing...25

Chapter 6 - Appendices...26

Appendix A: Maintenance and Care of the Recorder...26 Appendix B: Batteries...27 Appendix C: Pacemaker Detection...28 Appendix D: EMC Information...30 Appendix E: Extraction of ECG data on 3-channel...34 Appendix F: Accessories...34 Appendix G: Test Issues...35

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Chapter 1 -Introduction

The NorthEast Monitoring DR200/HE and DR300 Digital Recorders can be used as either a Holter monitor or a looping Event recorder. The DR200/HE and DR300 Digital Recorders are designed to facilitate ambulatory cardiac monitoring, on order of a physician, of those patients (including infants weighing less than 10 kg.) who may benefit from such monitoring, including but not limited to those with complaints of palpitations, syncope, chest pains, shortness of breath, or those who need to be monitored to judge their current cardiac function, such as patients who have recently received pacemakers.

The data obtained by monitoring is not analyzed at the time of recording. After the recording is complete, the data must be downloaded to a compatible version of NorthEast Monitoring, Holter LX Analysis or LX Event software to be analyzed.

The DR200/HE and DR300 Digital Recorders are compatible with 5.2 or newer versions of Holter LX Analysis. The DR300 Digital Recorder in wireless mode for event recording, is compatible with LX Event version 2.11 or newer.

Specifications

The DR200/HE and DR300 digital recorders are not intended to replace real-time telemetry monitoring for patients suspected of having life-threatening arrhythmias and is not for In Vitro diagnostic use.

Physical Specifications

The DR200/HE & DR300 Digital Recorder meets the following physical specifications:

• Size: 8.6 cm (length) x 6.0 cm (width) x 2.0 cm (depth)

• Weight: 70.9 grams (2.5 oz.) without battery; 99.3 grams (3.5 oz.) with battery

Electrical Specifications

The DR200/HE & DR300 Digital 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

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DR200/HE & DR300 Operator’s Manual Introduction: Intended Use

Power Supply

The DR200/HE & DR300 Digital Recorder is powered by one 1.5 volt AA battery, not included. An AA alkaline battery (MN1500 or the equivalent), a AA rechargeable NiMH (nickel metal hydride) battery, or oa AA Eveready Lithium L91 battery can be used. Although battery life may last longer than a recording, batteries should not be re-used for a second patient. After one use, they should be disposed of following local ordinances.

Do not leave battery in the recorder for extended periods (more than two weeks) when the recorder is not in use.

If you use rechargeable batteries, the battery recharger should be kept out of the patient environment and hook-up area. For details about recommended batteries/chargers, see Appendix B.

Environmental Specifications

Wireless Specifications

The DR300 recorder is equipped with wireless Bluetooth transmitter. A NorthEast Monitoring DR300 Gateway and Bluetooth USB Dongle is able to receive the encrypted Event and Holter data. (The USB Dongle only works with Event data.) The Bluetooth specifications for the DR300 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

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 700 and 1060 hPa pressure.

Store and/or transport the recorder at temperatures between -40 and 70 degrees C, between 10 and 100% relative humidity, and 500 and 1060 hPa pressure.

The recorder has an Ingress Protection Marking of IP22. The solid particle protection is level 2 as the device is protected against objects > 12.5mm, such as fingers or similar objects. The liquid ingression protection is level 2, which meant that vertically dripping water shall have no harmful effect when the enclosure is tilted at an angle up to 15° from its normal position.

• Holter Mode: Detection of Arrhythmias,

Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.

• Event Mode: The event recorder module is

a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain).

Indications for Use

1. Detection of Arrhythmias: The DR200/

HE & DR300 Digital Recorder is indicated for use in continuous monitoring of cardiac rhythm when intermittent arrhythmia are 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: The DR200/HE &

DR300 Digital Recorder is indicated for use to determine whether current pharmacological treatment(s) of known arrhythmia is effective by measuring the frequency and

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DR200/HE & DR300 Operator’s Manual Introduction: Warning Symbols

duration of the arrhythmia compared to the frequency and duration prior to treatment.

3. Pacemaker Evaluation: The DR200/HE &

DR300 Digital Recorder is indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits.

4. The DR200/HE & DR300 Digital Recorder

is to be used only on the order of a physician.

Warning Symbols

Please note that the recorder is labeled with the following warning symbols:

.Refer to 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.

This product does not contain lead.

Caution: Federal law restricts this device to

sale by or on the order of a physician

LCD Display

The recorder has an LCD screen that is used to display either time-of-day (during the recording), prompts and error messages (during the hook-up procedure or during recording), and lead quality (during the Holter hook-up procedure). For details about the information displayed on the LCD, refer to the hook-up directions that follow.

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 equip-

ment 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

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DR200/HE & DR300 Operator’s Manual Introduction: Patient Leads

to the equipment without the approval of manufacturer could void the user’s authority to operate this equipment.

Patient Leads

The recorder is compatible with standard single-use silver/silver-chloride ECG electrodes. The recorder uses NorthEast Monitoring shielded patient cables with either seven leads or five leads for a 3-channel Holter recording, or three leads for 2-channel Holter recording. For event recording, a 2- or 3-lead shielded patient cable is used. The patient cable connects to the recorder via a 7-pin in-line receptacle.

Patient electrodes should not be applied to anything except the patient. Patient electrodes should be left sterile in their original packaging until use. Follow manufacturer’s instruction for use, and discard after use. Dispose of electrodes following local ordinances and the manufacturer’s instructions.

Patient lead wires and cables should be cleaned and disinfected as required between uses, with 70 percent isopropol alcohol and a soft cloth to disinfect, and a non-abrasive liquid soap and soft cloth to clean. Sterilization is not required.

Storage Capacity

The patient’s Holter data is stored in the recorder on a removable SD Card. To store 24 hours in normal mode, the minimum capacity of the SD Card should be 28 megabytes; 56 megabytes are required for 24 hours in high resolution mode.

There are some SD Card types that may draw excessive power, and will therefore drain the battery prematurely. If you purchase cards from a supplier other than NorthEast Monitoring, it is recommended that you first test the SD card for a greater amount of time than the expected use.

The patient’s Event data is stored in non-volatile memory internal to the recorder.

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.

Note: Do not pull on or stretch the patient cables or lead wires when you clean them. This can cause premature failure of the cable. Instead, lay the cable and attached wires on a clean, flat surface, hold them down with one hand, and holding a cloth in the other hand, rub all surfaces of the cable.

See Appendix A for details about cleaning and disinfecting the recorder as needed.

Patient lead wires and cables should be visually inspected between uses for worn or cracked areas. Frequently used cables should be replaced at least every 6 months. Worn lead wires and cables should be replaced before next use and disposed of following local ordinances and manufacturer’s instructions.

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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.

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DR200/HE & DR300 Operator’s Manual Introduction: Operating the Recorder

Operating the Recorder

If you require 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.

The DR200/HE and DR300 Digital Recorders contain no user-serviceable 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 866346-5837, 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 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 web site, www.nemon.com or by emailing technical support at [email protected].

Our “Technical Support” page on the web-site includes Frequently Asked Questions.

Wireless Bluetooth (DR300 only)

The DR300 digital recorder is enabled for wireless Bluetooth trans-

mission. In order for wireless transmission to occur, the DR300 needs to come in range of a NorthEast Monitoring transceiver either a Gateway or a paired USB Bluetooth adapter. Additionally, the appropriate software, either the DR300 Socket or DR300 Bluetooth, must be running on the computer that the transceiver is connected to.

Note: Refer to the DR300 Gateway and Socket Technical Manual, NEMM046, for information on how to set up and run the wireless feature.

If there is sufficient data to send and Wireless is turned on, the recorder will attempt to locate a Gateway every 20 minutes. When a paired Gateway is found, the data will attempt to be sent. If a paired Gateway is not found, and the recorder is in Event mode, it will attempt to look for a paired Bluetooth Adapter on a PC to send the data.

Note: If you are using the USB Bluetooth adapter, there can be only one paired adapter in a given location, such as an office.

At any point, if there is at least one event or 20 minutes of Holter data, the user can force the process by pressing the ENTER button on the recorder. For a Holter Bluetooth transmission, only manually initiated transfers are allowed. This ensures that only one recorder is transmitting at one time while in the office.

The most current version of this manual, the warranty and our software can always be found on our web-site on the “Downloads & Documents” page.

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DR300 Tablet App

Because of the DR300’s unique Bluetooth capability, you can use an Android tablet to set up and start the DR300. The DR300 tablet App is downloadable via Google Play and more information can be found in Chapter 5- DR300 Tablet.App.

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Chapter 2 -Holter Recording

The Holter Recording Procedure

To use a DR200/HE or a DR300 digital recorder to record a patient’s long-term ECG (Holter), follow the appropriate steps listed below:

Step 1 - Hook-up patient;

Step 2 - Prepare the recorder

Step 3 - Enter patient ID on recorder;

Step 4 - Start recording.

These steps are described in detail starting with the next section.

If you have a new SD Card that has not been formatted with a flash.dat file, you will need to use your NorthEast Monitoring, Inc. Holter LX Analysis software to initialize the card for the first time.

When the recording is finished, simply remove batteries to stop recording.

Step 1: Hook-up Patient for Holter

The most important element in Holter monitoring is recording a clean long-term ECG signal. Because a clean signal is directly dependent on the hook-up procedure, great care should be taken when hooking up the patient. Poor hook-up causes poor signal quality and artifact.

To ensure proper hook-up, follow these steps:

1. Using either the 5-Lead (3-channel) or 7-Lead (3-channel) hook-ups shown, identify

sites for the electrodes. You can also choose a 3-Lead hook-up (2-channel) which is shown in the Event section of this manual.

2. Prepare the patient’s skin. If the patient has hair in any of the electrode areas, shave

it with a safety razor. Use an alcohol pad and rub the sites briskly until the skin reddens. Let the skin air dry before proceeding.

3. Attach the patient cable to the recorder. Next, snap a lead wire from the patient cable

to each of the electrodes.

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DR200/HE & DR300 Operator’s Manual Holter Recording: The Holter Recording Procedure

5-LEAD PLACEMENT

7-LEAD PLACEMENT

5-LEAD PLACEMENT

Channel 1:

+ Brown 5th rib, left anterior axillary line

- Red centered

Channel 2:

+ Black 5th rib, left of mid-clavicular line

- Red

Channel 3:

+ Black

- White right manubrium

Ground:

Green centered over rib

7-LEAD PLACEMENT

Channel 1:

+ Red 5th rib, left anterior axillary line

- White right manubrium

Channel 2:

+ Brown 2 cm. right of xiphoid process

- Black left manubrium

Channel 3:

+ Orange 5th rib, left of mid-clavicular line

- Blue centered on manubrium

Ground:

Green centered over rib

Note: The 7-lead hook-up shown below consists of independent bipolar leads and corresponds to IEC606012-47 requirements (Code 2). The 5-electrode hook-up does not have independent leads, and so, does not correspond to either Code 1 or 2, but is widely used in the United States and Canada.

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DR200/HE & DR300 Operator’s Manual Holter Recording: The Holter Recording Procedure

Using a clip lock electrode

Electrode

Tape

Stress Loop

4. Attach an electrode at each of the patient’s

prepared sites. As you attach electrodes, be careful to not let any unattached electrode come in contact with other conductive objects, including ground. Be sure to refer to the diagrams on the previous page for correct placement of each colored lead. The electrodes should be placed over bone at each of the sites. Press the center of each electrode against the patient’s skin, then rub the outer circle of each electrode to secure it.

5. If you use

lead lock or clip lock electrodes, be sure to use the lock or clip to relieve stress on each lead wire; refer to the diagram at right for proper use. Otherwise, tape each lead wire into a stress loop (see the diagram below) to help prevent movement of the electrode.

contacts down and toward the recorder as you gently push it in. Be sure to use the SD Card you formatted for this patient.

If the card pops out slightly when you push it in, try again. Pushing gently on the card

both inserts it and allows you to remove it. Never pull the card out as it will damage the recorder.

Note: The SD Card should slide in easily. Make sure you do not force the card in; if you force the card in upside-down or force the card out by pulling, it can damage the connector inside the recorder.

3. Insert a fresh 1.5 volt AA battery into the

battery compartment, being sure to orient it as indicated in the diagram inside the compartment. See Appendix B for details about battery choices.

4. Replace the battery cover by sliding it into

the card slot until it clicks.

5. “DR200/HE” or “DR300” will first appear

on the screen and then the NorthEast Monitoring information will appear. Press ENTER to continue.

6. If you did not erase the previous patient’s

data from the SD Card, you will now be prompted to Erase memory. Use the green arrows to select “*Yes” and press ENTER.

7. You will see ERASE DONE when erasing

is complete.

Step 2: Prepare the Recorder

After connecting the patient to the recorder, follow these steps to prepare the recorder:

1. Remove the battery cover from the back of

the recorder. The battery compartment and the SD Card slot are now exposed.

2. With the recorder front facing up and away

from you, insert an SD Card into the slot. The SD Card should have the connector

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Note: If at any time you need to restart the set up process, just remove the battery to begin again.

Note: If your recorder is in Event mode, the 15-second countdown will begin when you put in a new battery. To interrupt the 15second countdown, quickly press ENTER, down arrow, up arrow and then EVENT, in that order. You should now see the NorthEast Monitoring screen. Press ENTER to continue to the main menu.

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DR200/HE & DR300 Operator’s Manual Holter Recording: The Holter Recording Procedure

Step 3: Enter Patient ID

You will now see a screen with two choices: “New Patient” and “Settings”. Since the recorder will store settings between patients, you may only need to adjust settings when there is a time change or if you want to change between Holter and Event. For more information on adjusting settings, refer to Chapter 4 Recorder Settings and Messages.

1. If you would like to input the Patient ID at

this time, press ENTER and use the green up arrow to select the first character of the ID. Use the ENTER button when you have entered the first character and continue until all of the ID is entered. Once the patient ID is entered, press the EVENT button.

Note: If you make an error while entering a character into the Patient ID, you can backspace one or more times by holding down the Enter key for several seconds until the cursor moves to the left.

2. Now, the LCD will display the ECG sig-

nals, the battery level, and lead quality based on the level of impedance detected between the two electrodes for each channel. Lead quality for each channel is a number between 0 and 5. The best possible signal quality reading is 5; that indicates a good electrode-skin connection. A “0” indicates no signal is being received by on the recorder.

3. Once a satisfactory lead quality signal of 3

or more is displayed for all channels, continue with the final step - Start Recording.

Note: If you do not push the EVENT button, the recorder will display lead quality for 10 minutes, then start recording. To delay the start of recording, simply press the EVENT button briefly and the 10-minute countdown will start again.

Step 4: Start Recording

1. Once the LCD displays satisfactory lead

quality signals for all channels, you can start the recording by pressing the EVENT button for 3 seconds till you see “Recording Started”. If you do not do this, recording will begin automatically after 10 minutes. During recording, time-of-day appears on the LCD. Once recording begins, it will continue until the battery is removed or the SD Card is full.

2. The patient can choose between a belt clip

or pouch with strap for wearing the recorder. All equipment, except the electrodes and a portion of the lead wires, should be over at least one layer of clothing so that it is not in direct contact with the patient’s skin. Orient the recorder on the patient so that the EVENT button is accessible and the LCD is visible.

3. Advise the patient to not expose the

recorder or electrodes to any wet environment; in addition, they should not shower, bathe, or swim while wearing the recorder.

4. Instruct the patient on how to use the

EVENT button to indicate symptomatic events or activities of interest during the Holter test. Advise them to push the EVENT button briefly. The patient may also be given the opportunity to enter a diary at the time of the event. They should use the up/down arrows to choose the most appropriate entry.

The EVENT button then marks the recording so that when the Holter signal is analyzed, the ECG at the time-of-day the button was pushed is kept as saved strips and labeled as an event and with the selected diary entry.

5. When the patient returns, remove the elec-

trodes, leads and recorder from the patient. Open the recorder and remove the battery and SD Card from the recorder. Pushing

gently on the card both inserts it and allows you to remove it. Never pull the card out as it will damage the recorder.

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DR200/HE & DR300 Operator’s Manual Holter Recording: Power Loss Protection Feature

The Holter signal is now ready to be analyzed.

Note: For a DR300, instead of removing the SD card, you could choose to wirelessly transmit the recording using a paired Bluetooth adapter. Refer to the DR300 Gateway and Socket Technical Manual, NEMM046, for information on how to set up and run the wireless feature. If you are using the USB Bluetooth adapter, there can be only one paired adapter in a given location, such as an office.

Power Loss Protection Feature

In Holter recording mode, as of software version 4.41, if the battery is removed and reinserted within 12 hours, the recording will continue. (As of firmware version 1.09, restart time is up to 60 minutes, but for firmware versions 1.08 and earlier, it is only up to 10 minutes.)

When the battery is reinserted during the allowed time, the LCD returns to the time-ofday and continues to record the patient’s Holter signal. When the patient’s recording is analyzed, the signal recorded while the batteries were not in place appears as continuous highfrequency artifact in all channels.

If the battery is left out for more than 12 hours, recording cannot be restarted. Instead, you will have to use the recording as is, or you will have to re-initiate the recording after erasing the memory on the SD Card.

Note: If the SD Card has been removed and you wish to restart the recorder without a card in order to update settings, you will need to press the following buttons in this exact order during the 15 second countdown: ENTER, down arrow, up arrow, EVENT.

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Chapter 3 -Event Recording

Channel 1:

+ Red: 5th rib, left anterior axillary line

- White: Right manubrium

Channel 1 (Lead 1):

+ Black: Left-mid-clavicular

- White: Right mid-clavicular

Channel 2 (Mod V5):

+ Brown: 5th rib, left anterior axillary line

- White

The Event Recording Procedure

The DR200/HE and DR300 digital recorders can be used as a looping event recorder to capture events automatically or when activated by the patient. Based upon your settings, the recorder can capture up to 90 minutes of event recordings. When one or more events are captured, the patient may transmit his/her recordings transtelephonically.

Note: No SD Card is used during event recording.

To record in Event mode, follow these steps:

Step 1 - Hook-up the patient;

Step 2 - Prepare the recorder;

Step 3 - Start recording.

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DR200/HE & DR300 Operator’s Manual Event Recording: The Event Recording Procedure

12:33

Sent

10 / 100

Step 1: Hook-up Patient

The recorder uses a 2-electrode lead for 1channel or an optional 3-electrode lead for 2channel event recording.

Refer to Step 1: Hook-up Patient in the Holter Recording section of this manual for hook-up instructions, but refer to the 2- or 3-electrode diagram on this page for electrode placement instructions.

Step 2: Prepare the Recorder

After connecting the patient to the recorder, follow these steps to prepare the recorder:

1. Remove the battery cover from the back of

the recorder. Now the battery compartment and the SD Card slot are exposed.

2. If there is an SD Card in the recorder, it

should be removed for event recording as it will drain the battery unnecessarily. To remove the SD Card, gently press on it and it should pop out slightly. You should be able to pull it out easily. If it doesn’t work the first time, try again.

3. Insert a fresh 1.5 volt AA battery into the

battery compartment, being sure to orient it as indicated in the diagram inside the compartment. The battery sits loosely in the compartment. See Appendix B for details about battery choices.

4. Replace the battery cover by sliding it into

the slot until it clicks.

5. The text “DR200/HE” or “DR300” will first

appear on the screen and then after 10 seconds, the recorder will begin counting down from 15 seconds and will automatically begin recording. The time-of-day and battery level will appear on the display once recording has begun. If LCD also shows events stored on the recorder, regardless of whether they are sent, you need to erase them now.

6. If the recorder is in Holter mode, you will

get an error asking for an SD Card which will then alternate with a 15-second countdown. Interrupt the countdown with the

button sequence, ENTER, down arrow, up arrow and EVENT and the go to the General Settings menu to change the Recording Type from Holter to Event. After doing that, go back to “Return” on the menus until recorder and the 15-second countdown begins again. Event recording will start after 15 seconds.

To Erase Events: If the previous patient’s events still exist on the recorder and they have been transmitted or stored, you will see the word “Sent” on the

LCD screen and you must erase the events before hooking up the new patient. To erase the events, hold down either green arrow button for 3 seconds. You will see “ERASING MEMORY” and once memory has been erased, the event counter at the bottom of the LCD screen will be reset and the word “Sent” will be replaced with the word “Recordings”.

If the previous patient’s recordings were not “Sent” then you will need to transmit or store event data before erasing. For more information on saving event data, refer to “To Transmit or Store Events” on the next page.

To Adjust Settings: In order to adjust settings, you will need to press the following buttons in this exact order during the 15 second countdown: ENTER, down arrow, up arrow, EVENT. While in Event mode, to restart the countdown, simply remove and reinsert the battery.

For more information on settings and how to adjust them, refer to Appendix C.

Note: If at any time you need to start the set up process over, just remove the battery to begin again.

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DR200/HE & DR300 Operator’s Manual Event Recording: To Transmit or Save Events

Step 3: Start Recording

1. The recording will begin automatically after

15 seconds. At first you may see the ECG signal and quality on the screen. The quality can range anywhere between 0 (no signal) to 5 (best signal). A rating of 3 or above should suffice, although you may want to get a signal of 5 before continuing. To view the ECG again, just remove the cable and re-insert. There will be a 10-second delay.

2. During recording, time-of-day appears on

the screen. Once recording begins, it will continue to record until the battery is removed or the memory is full.

3. The patient can choose between a belt clip

4. Advise the patient to not expose the

recorder or electrodes to any wet environment; in addition, they should not shower, bathe, or swim while wearing the recorder.

5. Instruct the patient how to use the EVENT

button to record symptomatic events. Advise them to push the EVENT button briefly; when they use it depends on your institution’s procedures.

Note: Although the recorder’s false negative rate is low, there is always the potential that an arrhythmic event being experienced by a patient is not captured automatically by the recorder. Therefore, we strongly recommend that even when automatic detection is turned on, that patients be informed that they should always press the EVENT button when they feel they are having an arrhythmic event.

6. If you choose, instruct the patient when and

how to send the recordings via the telephone.

7. When the patient returns, review the screen

first to ensure that all events have been sent.

8. If the screen states that there are “Events

Recorded” and does not state that any were “sent”, you will now need to transmit and save the events for the patient.

To stop recording

After transmitting and erasing any unsent events, remove the electrodes, leads and recorder from the patient. You should now open the recorder and remove the battery to stop operation.

To Transmit or Save Events

At the beginning of the transmission a cal signal will be present. Additionally, at the beginning of each event there will be a marker. The marker is a digital signal that will include the serial number of the recorder and the time, date and type of each event. The digital signal can only be read by the NorthEast Monitoring LX Event software. If you are using a different event recorder software, you will not be able to read the digital signal, but the signal will allow you to tell where each event begins.

There are a few ways to obtain the event data that has been saved on your recorder:

1. Acoustic Transmission

Start the software application or recording device that will be recording the events. Once recording has begun, press the ENTER button on the recorder for a second and the events will begin transmitting. Transmission will continue until all events are sent. Once the events are sent, you can now erase them from the recorder by pressing either one of the green arrows for 3 seconds.

The recorder’s ECG transmission uses the standard FM transmission. The header uses a proprietary format.

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DR200/HE & DR300 Operator’s Manual Event Recording: To Transmit or Save Events

2. SD Card storage

LX Event users can choose to store events on an SD Card. Before an SD Card is used for the first time, it must be formatted using the LX Event software. Also, only one set of data can exist on a card at any one time, so be sure that you save the previously stored data on the computer before beginning. (For more information on formatting the SD Card, please refer to your LX Event Software manual.)

To record the events onto a pre-formatted card, refer to the following steps:

1. Remove the battery cover from the back of

the recorder. The battery compartment and the SD Card slot are now exposed.

2. With the recorder front facing up and away

from you, insert an SD Card into the slot. The SD Card should have the connector contacts down and toward the recorder as you gently push it in. If the card pops out slightly when you push it in, try again. Pushing gen-

tly on the card both inserts it and allows you to remove it. Never pull the card out as it will damage the recorder.

Note: The SD Card should slide in easily. Make sure you do not force the card in; if you force the card in upside-down or pull it out, it can damage the connector inside the recorder.

3. Re-insert the battery into the recorder, being

sure to orient it as indicated in the diagram inside the compartment.

4. A message on the LCD screen will now

appear - “COPYING EVENTS.” When the events are finished being copied to the SD Card, you will see the message “FINISHED REMOVE CARD.” Do as you are told by gently pressing down onto the SD Card. It should pop out.

5. You should now insert the SD Card into your

reader and save the data on your computer using the LX Event software. If you use the

card again before saving on your computer, the data will be lost.

6. Once the events are saved on the desktop, re-

insert the battery into the recorder and see

the word “Sent” on the screen above the Event tally. You should now erase the events from the recorder by pressing either green arrow for 3 seconds.

3. Wireless Transmission (DR300 only).

Refer to the DR300 Gateway and Socket Technical Manual, NEMM046, for information on how to set up and run the wireless feature.

In short, if you choose to do a wireless transmission, you must turn on the Wireless setting on the DR300 and send the patient home with the paired Gateway. Then, the DR300 Socket program will collect and save event files during the procedure.

If the DR300 recorder returns with unsent procedures and Wireless is turned on the recorder, then you can use the paired Gateway or a local Bluetooth adapter to record the events in the office. Pressing the ENTER button will initiate the transfer of data locally. Be sure to immediately delete the events by pressing a green arrow for 3 seconds, or the events may be resent.

Note: If you are using the USB Bluetooth adapter, there can be only one paired adapter in a given location, such as an office.

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DR200/HE & DR300 Operator’s Manual Event Recording: Event Recording: Patient Operating Instructions

12:33

Recordings

10 / 100

12:39

Sent

10 / 100

Event Recording: Patient Operating Instructions

The recorder is ready to use when you receive it from your physician or nurse.

To Hook-up:

You will want to reapply fresh electrodes daily. To do this, simply snap lead wires into new electrodes first and then apply according to the technician’s instructions. We recommend that you do this after bathing or showering as the recorder or electrodes should not get wet.

To Record an event:

If your recorder has an automatic mode, the recorder may record events without your knowledge. This is normal operation and you may hear a beep when the recorder is recording an event.

If you feel that it is time to record an event manually, simply press the EVENT button and hold for a second. If your recorder is set up to accept a diary entry, you will see the word “Manual Event” on the recorder. No further action from you is required.

After recording is complete, the screen will show the time, the word “Recordings” and a tally showing the number of events that were recorded and the total number of events that can be stored on the recorder. In this example, the patient has 10 events recorded out of a possible 100:

To Send events manually:

If you have been instructed by your technician to call the receiving center after time has passed or a certain number of events have been recorded. Your recorder may even beep and/or display a phone number when it is time to call. When it is time to call, please do the following:

Step 1: If the recorder is in a pouch, remove the cable from the recorder and remove the recorder from the pouch. If the recorder is not in a pouch, it is not necessary to remove the cables from the recorder at this time, but you can do so if it makes it easier for you. Now, set the recorder on a flat surface with the screen side up and within reach of your telephone.

Note: Cell phones DO NOT work for sending transmissions.

Step 2: Call the receiving center phone number provided by the technician.

Step 3: When the phone is answered, follow the instructions given to you by the technician on the other end of the line.

Step 4: When instructed to “send your events”, do the following:

1. Press the ENTER button that is located on

the bottom left corner of the recorder.

2. Gently rest the telephone on the table with

the mouthpiece over the speaker that is located between the ENTER button and the down green arrow on the recorder.

3. The screen will display a message “Sending

Event” with the number of the event that the device is currently sending and the total number of events it needs to send. (You may also be able to hear the events being sent over the phone line.) This process may take just a few or many minutes depending upon the number of events recorded and the amount of time of each event.

4. Once all the events

are sent, you will now see that the word “Sent” has replaced the word “Recordings”. This means that all of the events in the recorder have been sent, but are still saved.

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DR200/HE & DR300 Operator’s Manual Event Recording: Event Recording: Patient Operating Instructions

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Recordings

0 / 100

Step 5: At this time the technician may ask you to erase your events by pressing either of the green arrow buttons down for 3 seconds, but you SHOULD ONLY ERASE EVENTS WHEN INSTRUCTED TO DO SO. Once events are erased, you will see that the first number is changed to 0 as there are no longer any events stored on the recorder. You are now ready to record new events.

Wireless Event Transmission:

If your DR300 digital recorder is set up to do automatic wireless transmissions, you do not need to send events manually. Instead, when the recorder comes in contact with the NorthEast Gateway box, that has been provided to you, it will automatically send any events that are saved every 20 minutes.

Cleaning

You can clean the outside of the recorder with a soft cloth.

your next transmission is successful, be

sure to replace the battery before you send any transmissions to the receiving center.

• Battery FAILURE: Recording has

stopped. Replace the battery as soon as possible.

• LEAD LOOSE: This error will occur when

there is a problem with the patient hook-up. The problem may be with an electrode, a lead, or the cable that connects the leads to the recorder. Please check all of the connectors to be sure that they are still in place. If you continue to see this error after 10 seconds, call the receiving center for further assistance.

Batteries

Your battery should last for the duration of your test, but if you need to change the battery, you can do so at any time and not lose any event data stored on the recorder.

To replace the battery, insert a blunt object (for example, pen, coin or non-pointy tool) in the space between the battery and the top edge of the recorder. Press gently to easily remove the battery.

LCD Screen Messaging

Error messages may occur during recording. If you see an error message that is not listed on this page call your receiving center for further instructions.

• If the time and event tally appears on the

screen, this is normal and means that the recorder is functioning appropriately.

To insert a fresh battery into the battery compartment, be sure to orient it as indicated in the diagram inside the compartment. The battery sits loosely in the compartment.

Note: Do not leave batteries in the recorder for extended periods (more than two weeks) when the recorder is not in use.

• If the screen is blank, this means that the

recorder is not working. It is possible that the battery no longer has enough power. Try putting in a fresh battery, but if this does not solve the problem, call your receiving center for further instructions.

• Battery LOW: Battery power is running

low. When this message first appears, you will have about 5 days of recording time left on your battery. In order to ensure that

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Page 19

Chapter 4 -Recorder Settings,

Error Messages and Troubleshooting

For Holter recording, you can adjust settings on the recorder between patients only. To begin, insert a battery to start the recorder.

If 15-second countdown occurs

If your recorder is in Event mode, the 15-second countdown will begin when you put in a new battery. To interrupt the 15-second countdown, quickly press ENTER, down arrow, up arrow and then EVENT, in that order. You should now see the NorthEast Monitoring screen. Press ENTER to continue to move to the main menu.

To Adjust Settings

To adjust the settings, use the green arrows to move up and down between the menu items and ENTER to accept. The cursor “>” will appear next to the item that you are able to update. Press ENTER to begin updating that item, and then use the green arrows to adjust the value. When finished adjusting a value press ENTER to save the value. To return to the previous menu, use the green arrows to move the arrow to “Return” at the top of the menu and press ENTER.

To Review Settings

At any time, you can remove the battery from the recorder and re-insert. Then interrupt the 15second countdown as instructed above. You can now review settings without losing any event data.

To Update Time and Date

The recorder should save the correct time and date between uses, but if you ever need to update the time or the date, move the cursor to “Time and Date” and press ENTER. You can now update Hour, Minutes, Day, Month or Year by moving the cursor with the green arrows and pressing ENTER.

About

To view the Serial No, the customer code (cc), the Version number of the software on the recorder, the build number for that software, and the number of times the recorder has been used in Holter mode.

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Page 20

DR200/HE & DR300 Operator’s Manual Recorder Settings, Error Messages and Troubleshooting:

To Update General Settings

Contrast. Use arrows to increase or decrease contrast.

Lead Loose.

• On - Lead Loose message is enabled.

• Off - Lead Loose message is disabled.

Event marker. When on, the ECG will be labeled with one second of 6-cycle square wave where the event took place.

Key mode.

• Normal - Sound enabled and no delay;

• Delayed - Patient will need to press Event

and Enter buttons for several seconds in order to prevent false entries, and sounds enabled; or

• Quiet - Sound disabled. No delay.

Rec Type. Switch between Holter, Event and Both-HE recording. The Both-HE setting is for Event recording where you desire a Holter back-up file to be saved. For Both-HE, you will need to put an SD flashcard with a flash.dat file into the recording as if you were doing a Holter recording. The flash.dat file should be large, so chose “file as large as card” from the Initialize Flashcard options in Holter LX Analysis.

Menu Lock. Menu Lock will prevent anyone from reviewing or updating any other settings.

• To lock the menu, enter 217.

• To unlock the menu, enter 151.

Language. Select from U.S. English, International English, Danish, Finnish, German, French, Italian, Norwegian, Polish, Portuguese, Russian, Spanish and Turkish.

Diary. When the Diary is turned On, the patient will be able to select a symptom during a manual event. During Event recording only, Post Event Seconds must be is set to 30 or greater, for the Diary options to be displayed to the patient.

Hi Res / ch: For release 4.46, only 3 channel and Hi Res recording function correctly. Holter 1 & 2 channel should not be used.

When turned On, the recorder will record Holter in high resolution. High resolution mode provides enhanced R-wave reproduction for pediatric recordings.

Wireless. (DR300 only) When the Wireless setting is turned On, the DR300 recorder will transmit saved event or Holter through a paired NorthEast Monitoring Gateway box.

Note: Each Event must be 8 minutes (480 seconds) or shorter in length in order to be transmitted via the Gateway.

The URL settings tell the recorder where to ultimately send the data when Wireless is turned on. The URL settings are pre-programmed and cannot be changed by the technician.

Pair Bluetooth - Refer to the DR300 Gateway and Socket Technical Manual, NEMM046, for information on how to set up and run the Wireless feature.

Event Settings

Pre Event Sec. The number of seconds saved before the EVENT button is pressed by the patient.

Post Event Sec. The number of seconds saved after the EVENT button is pressed by the patient. If this number is set to 15 seconds, the user will not be asked to select a diary entry after pressing the record button.

Max Events. Limits the number of events that are saved at any one time. A total of 90 minutes can be saved on the recorder. The maximum number of events may be automatically adjusted by the recorder based on the number of seconds saved for each event as well as the number of channels.

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Page 21

DR200/HE & DR300 Operator’s Manual Recorder Settings, Error Messages and Troubleshooting:

Channels. For event recording, the recorder can record either one or two channels. If two channel recording is selected, the recorder will transmit both channels sequentially during the transmit process. A 3-lead cable is required for 2 channel recording.

Acoustic mode settings

Note: LX Event version 2.11c and earlier versions support acoustic mode for event recording.

Note: These settings are disabled if a DR300 is set to transmit wirelessly.

Send Setting. The Speed setting allows you to transmit either 1, 3 or 4X speeds.

Call message. Once events are recorded, you can inform the patient with either a sound or a phone number on the LCD screen:

• Phone Num - Will show the entered phone

number on the LCD screen after events are recorded. “Any” will show number if there is one or more events, “Full” will show number only if maximum number of events have been recorder.

• Enter Phone Num - Enter the phone num-

ber that the patient should call when events recorded. Use green arrows to update digits. Hold down ENTER button to backspace.

• Reminder - Will cause the recorder to beep

repeatedly after events are recorded. “Any” will beep if there is one or more events, “Full” will beep only if maximum number of events have been recorder.

Auto Detect Settings

Auto Detect. Turns auto detection On/Off for all event types, including AF.

AF Detect. Only turns Atrial Fibrillation detection On/Off.

AF Peak HR. The minimum HR that at least 3 beats of the previous 20 must exceed, in order for an event to be called AF. The range s 60 120 BPM.

Brady Limit. If a heart rate on or below this number is detected, an event will be recorded. A range of 20 - 100 BPM is allowed.

Tachy Limit. If a heart rate on or above this number is detected, an event will be recorded. A range of 50 - 300 BPM is allowed.

Pause Limit. If no heart beat is detected for at least the pause length in seconds, an event will be recorded. A range of 1.0 to 10.0 seconds is allowed.

Separation. There are two options. Both limit the number of events by type by requiring a minimum amount of time between the same type of event.

• The first, Min Time, applies to all events,

except AF. A range of 2 - 20 minutes is allowed.

• The second “Min AF time”, applies to AF

events only. A range of 2 - 90 minutes is allowed.

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Page 22

DR200/HE & DR300 Operator’s Manual Recorder Settings, Error Messages and Troubleshooting: Error Messages

Error Messages and Troubleshooting

If you see the time-of-day on the recorder screen, the recorder is recording.

Note: If the LCD screen is completely blank, this means that the recorder is not recording.

An error message will appear when there is a problem with the recorder. The recorder may display the following error messages:

Battery LOW: Battery is running low. When this message first appears, you will have about 5 days of recording time left on your battery.

Battery FAILURE: Recording has stopped.

Card Erase ERROR: An error was found

while attempting to erase the SD Card. This usually means a defective card.

LEAD LOOSE: This error will occur when there is a problem with the patient hook-up. The problem may be with an electrode, a lead or the cable that connects the leads to the recorder. The LEAD LOOSE message will remain on the screen for about 10 seconds after the problem has been corrected. This error message can be turned off in General Settings.

Explorer to identify and delete these files. The only file allowed is flash.dat.

Short recording: There are some SD Card types that may draw excessive power, and will therefore drain the battery prematurely, resulting in a short recording. If you purchase cards from a supplier other than NorthEast Monitoring, it is recommended that you first test the SD card for a greater amount of time than the expected use.

Unable to write SD: An error was found while attempting to write to the SD Card. This message occurs when the card is full. Sometimes this message will appear when a card is defective.

Write Timeout error: This usually means a defective card.

Missing SD Card: There is no SD Card in the device. A card is required for Holter recording.

SD Access: Unable to read the SD Card. This usually means a defective card.

SD Card is write locked: Write Lock tab is set on the SD Card. Unlock Write Lock tab and try again.

SD Setup Failure: Failure during write of patient ID to SD Card. You will need to re-initialize your card using the LX software.

SD Card Incorrectly erased: There may be disallowed files on the SD Card. Remove SD Card from recorder and use card reader and

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Page 23

Chapter 5 -DR300 Tablet App

The DR300 Android Tablet Application allows you to update recorder settings, view ECG signals, and start the DR300 recorder all from your tablet.

Installing the DR300 Tablet Application

The DR300 Tablet App was tested on a Samsung tablet and requires Android version 5.1. The DR300 Tablet App can be found and downloaded via Google Play. There is no cost for this application. Install the App onto your tablet before pairing with the DR300 recorder.

Pairing the recorder with the Tablet

Before pairing, make sure that there are no events or a flash.dat card with data that you want to keep in the recorder.

1. First, start the DR300 recorder and go to Settings > General Settings > More > Wireless >

Pair Bluetooth. At this point the DR300 recorder turns on its Bluetooth and looks for a pairable device. If it is not already paired, it should respond with “no connection”. That is good. Leave the recorder at this screen.

2. Next, go to the Bluetooth Settings on the tablet. You should see the DR300 recorder on the list

of devices that have been found under “Available Devices”. Click on the recorder that you want to connect to.

3. The tablet should ask for you to Confirm the pairing. Do so.

4. Shortly thereafter, you should see “Found Tablet” appear on the DR300 recorder.

5. Now, restart the recorder by removing and reinserting the battery. Once you see the initial

splash screen, with “NorthEast Monitoring” at the top, you can start using the DR300 Tablet App with the DR300 recorder.

Note: If you keep seeing the 15-second countdown, quickly press ENTER, down-arrow, uparrow and EVENT buttons to interrupt. If it asks if you want to erase data, you still have a card with data on it in the recorder. You may want to remove it to save.

Starting the DR300 Tablet App

First, open the DR300 Tablet App. Next, start the DR300 recorder by inserting (or removing and reinserting) the battery. Once the DR300 is on the initial splash screen t,hat shows “NorthEast Monitoring” it will attempt to connect to the DR300 Tablet App.

Note: When using the Tablet to configure or start a DR300 recorder, only one DR300 should be available at any given time.

The recorder’s Serial No. should now appear on the DR300 App screen. The recorder’s Serial No. can be found on the recorder About screen and in the battery compartment on the back of the DR300.

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Page 24

DR200/HE & DR300 Operator’s Manual DR300 Tablet App: To Update Settings on DR300 Recorder

DR300 App Splash Screen paired with DR300

Connected to DR300

To update

settings

The menus on tablet

Menu to update settings

To Update Settings on DR300 Recorder

From the initial screen, press the CONFIGURE DR300 button on the tablet to update the settings on the connected recorder.

The DR300 Recorder Settings

On the left-side of the screen, you will see a similar menu to what appears on the DR300 recorder. You can go to any of the screens to see what the current setup is on the DR300 recorder. Click on any of these menus to review and/or update the settings.

Note: Refer to Chapter

Start the DR300 Recorder

Once connected, if the recorder has Recorder Type set to “Event”, you will see ‘START EVENT RECORDING” in the center of the screen, and you can press it to begin recording immediately.

recorder settings.

Update the Recorder

4 of this manual for more information on the

If the connected recorder has Recorder Type set to “Holter” or “Both” you will see “START SIGNAL QUALITY TEST” in the center of the screen. At this point you can enter the Patient ID and start the signal quality test to see the hook-up and begin recording. u

The Signal Quality Test

When recording Holter or Both, the Signal Quality Test will display up to 3 channels for you to ensure that your patient is hooked-up correctly Once you are satisfied with the quality of the signals, click on the arrow at the top of the tablet screen to begin recording.

that you can use to update the Tablet:

Once the settings on the tablet are what you desire, click on the 3stacked dots on the upper-right side of the screen to get to the dropdown menu. Click on “Send Settings to Recorder” to update the DR300 with what you entered on the tablet.

The menu also includes the following options

• Recall Saved Settings - If you previously saved

Settings on the Tablet for future use, this will update the Tablet with those saved settings

• Recall Factory Settings - Will update the Tablet

with the Factory Settings

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Page 25

DR200/HE & DR300 Operator’s Manual DR300 Tablet App: Live ECG Viewing

• Save Recorder Settings on Tablet - Saves the

settings you just entered onto the Tablet for future use

• Update Time - Will automatically update the

time and date on the recorder to match the tablet

The Wireless Settings

The Wireless Settings menu is where you can turn Wireless On or Off. When Wireless is turned On, the DR300 recorder will transmit saved event or Holter through a paired NorthEast Monitoring Gateway box.

The other items on the Wireless Settings show you whether the recorder is paired and how your recorder is set up for transmitting.

Note: Refer to the DR300 Gateway and Socket Technical Manual, NEMM046, for information on how to set up and run the Wireless feature.

Locked Recorder

Locked recorders cannot be updated or started with the Tablet. To update settings on a locked recorder, you will need to first unlock the recorder by going to Settings > More > Menu Lock, and entering:

Troubleshooting

If DR300 Android App is not connecting with the DR300 recorder that you want to configure and/or start, you may want to try one or more of the following:

• Close and restart the DR300 Tablet App

• Make sure you have the correct recorder Serial

No.This can be found on the DR300 About screen and in the battery compartment on the back of the DR300.

• Make sure that only one DR300 recorder is open

to its Splash screen.

• Check to make sure that the DR300 is Paired

with the tablet. You should see the recorder Serial No. on the Tablet’s Bluetooth screen.

• If open, close the DR300 App and restart it.

• If Paired, then turn off the Bluetooth and then

turn it back on again on the tablet. Also close and restart the DR300 App. Once restarted, make sure that the recorder’s Serial No. is still visible on the Paired list.

• Restart the DR300 recorder be removing and

reinserting the battery.

• Make sure that there are no unerased events on

the recorder.

• 217 to lock the menu

• 151 to unlock the menu.

Live ECG Viewing

Additional Notes:

•

If you switch the recorder from Event to Holter recording mode, the recorder will restart and you may need to enter the Patient ID two times.

• If you turn of the tablet’s Bluetooth radio will

If the recorder is in Event or Holter recording mode (not Both), at any point during recording you can view the live ECG signal on the recorder and/or a Tablet with the DR300 App turned on.

In order to view the live ECG signal on the recorder, start the DR300 Tablet App, and then press the arrows in the following order - up, down, up, down. At that point the live ECG signal should appear on the recorder screen and will transmit to a tablet when available.

To stop viewing, press the record arrow in the upper-left corner of the Tablet App. On the recorder, press the down-arrow to stop live viewing.

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the DR300 Tablet software is not closed, the software will go into a continuous mode looking for the Bluetooth. Close the software and restart to fix.

• The DR300 recorder will restart, if you close the

software while connected to the recorder.

Page 26

Chapter 6 -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 a non-abrasive liquid soap, as required. DO NOT use any abrasive cleaners, such as acetone, on the outside of the recorder.

Note: Always remove the battery before cleaning 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 wrap the lead wires tightly around the recorder after each use. This can damage them.

Do not pull on or stretch the lead wires when cleaning or untangling them. This can damage them.

Do not clean the cable with harsh chemicals, such as acetone.

Do not submerge the recorder or its cables in water.

Replace the cable on a regular basis or at the first sign of damage.

At the end of their useful lives, all NorthEast Monitoring Inc. products should be disposed of following local ordinances.

To Remove Belt Clip

If you need to remove the belt clip, you will need a long flat tool like a screw driver. In order to remove the clip, one has to slightly pry up the end of the clip near the battery cover while pulling the clip out.

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Page 27

DR200/HE & DR300 Operator’s Manual Appendices: Appendix B: Batteries

Appendix B: Batteries

The recorder uses one AA-size battery. This requirement may be fulfilled in a number of ways. Battery types available on the market are:

• Alkaline (example: Eveready Energizer E91, Duracell NM1500)

• Heavy Duty

• Nickel Metal Hydride (example: MAHA AA 1800 mAh, Rayovac 1600 mAh NiMH)

• Nickel Cadmium (NiCd)

Alkaline

The alkaline is the most common type of battery. When a new, properly stored battery is used, a recording time of 30 days can be expected in event mode and 14 days in Holter. When the DR300 is used in wireless mode, Holter recording can be expected to be up to 7 days before a new battery is required.

While a recording that runs for 24 hours will in theory use less than half the capacity of the battery, using a battery for two different patients’ 24hour recordings is not recommended. The risk is that the "second" recording will not reach 24 hours.

The primary limitation of this battery type is that there is only a limited ability to test the battery before it is used. Unfortunately, at times a defective battery will appear to initially have full capacity, but will fail well before the expected time. The probability of this type of failure is very small when the batteries are obtained from the primary suppliers.

storage at a temperature below freezing will reduce battery life.

Heavy Duty

Batteries that are labeled "Heavy Duty" vary widely in capacity. The use of "Heavy Duty" batteries is not recommended.

Nickel Metal Hydride (NiMH)

This class of batteries is rechargeable and thus can be used in situations where a disposable battery is not desirable. Batteries of this type come in a range of capacities with the labeled capacity ranging from 1100 to 1800 mAh (milliamp hours). It is recommended that only batteries with a rating of at least 1500 mAh be used. Lower capacity batteries will operate the recorder for 7 days when they are new but after only a few uses may not be able to operate for the full 7 days. Recording time on the DR300 in wireless mode will be significantly less than when used nonwirelessly.

Charging these batteries is the most difficult part of their use. Only standard chargers that are specifically rated for use with NiMH batteries should be used such as the MAHA MH-204F or Rayovac 1-Hour charger; although medicallyapproved chargers can be used, they are not necessary. Older chargers designed only for NiCd (Nickel Cadmium) will overcharge this type of battery and can significantly shorten battery life. A charger that applies an excessive continuous charge can also shorten the battery life. If in doubt it is best not to leave the batteries on charge for long periods of time after the charger indicates a full charge.

The best prevention available against defective batteries is to obtain them from suppliers who do not store them for a long time and do store them properly. There are few requirements for storage of alkaline batteries. They should be stored at "room" temperatures (50-90 F) and in a dry location. There is no advantage to storing them in a refrigerator. There is actually a significant problem with low-temperature storage. Normal refrigerators have a very high humidity inside and this can cause a much greater reduction of life that is gained by the lower temperatures. In addition,

NorthEast Monitoring, Inc. NEMM019-Rev-O Page 27 of 35

Unlike the older rechargeable battery types, NiMH batteries have no real "memory." Thus they do not need to be completely discharged or "conditioned" to insure that they will fully charge. Doing a complete discharge will reduce the total life of the battery as every time the battery is discharged below about 25% capacity, the life of the battery is shortened more than for a normal discharge cycle.

Page 28

DR200/HE & DR300 Operator’s Manual Appendices: Appendix C: Pacemaker Detection

Most chargers for NiMH batteries depend on a property of these batteries that causes them to heat up when they have reached full charge. This has two consequences. First, if the batteries are being charged in pairs, the first battery to be fully charged will heat up and shut down the charge cycle. This can leave one of the batteries partially charged. Thus it is best to keep pairs of batteries together so they are both discharged and charged together. Secondly, if the battery is too warm for any reason, it may shut down the charge early. For that reason the batteries should be charged at normal room temperatures and it is often best not to cover the batteries in any way during the charge. Even the charger's own cover may reduce the charge. Leave the cover open during charging.

When the battery is not being charged, it will slowly discharge by itself. This type of battery will lose about one percent of its charge for each day. Most chargers will bring a partially charged battery up to full capacity in under an hour. Batteries that have not been used for over two weeks should be charged before use.

If used properly, these batteries will last for 300 to 1000 recordings of 7 days each. They will still not last forever. To control battery life, writing the date on the battery that the batteries are first put in service can be helpful.

Nickel Cadmium

This type of battery has less capacity than the NiMH and is not recommended. Also, disposal of this battery can pose problems.

Battery Replacing

Insert a blunt object (for example, pen, coin or nonpointy tool) in the space between the battery and the top edge of the recorder. Press gently to easily remove the battery.

To insert a fresh battery into the battery compartment, be sure to orient it as indicated in the diagram inside the compartment. The battery sits loosely in the compartment.

Appendix C: 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 which enhance the pace 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.

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DR200/HE & DR300 Operator’s Manual Appendices: Appendix C: Pacemaker Detection

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 micro-seconds 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.

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DR200/HE & DR300 Operator’s Manual Appendices: Appendix D: EMC Information

Appendix D: EMC Information

Attention should be paid to the following EMC information prior to installing or using the Northeast Monitoring DR200/HE or DR300 Digital Recorder device.

• Portable and mobile Radio Frequency (RF) communication equipment may interfere with the operation of the device.

Guidance and manufacturer’s declaration – electromagnetic emissions

The Northeast Monitoring DR200/HE and DR300 Digital Recorders are intended for use in the electromagnetic environment specified below. The customer or user of the Northeast Monitoring DR200/ HE and DR300 Digital Recorder should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment –

RF emissions CISPR 11 Group 1 Northeast Monitoring DR200/HE

• 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 DR300 Digital Recorders use 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

Harmonic emissions IEC 61000-3-2

Voltage Fluctuations/flicker emissions IEC 61000-3-3

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Not applicable

Northeast Monitoring DR200/HE and DR300 Digital Recorders are suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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DR200/HE & DR300 Operator’s Manual Appendices: Appendix D: EMC Information

Guidance and manufacturer’s declaration – electromagnetic immunity

The Northeast Monitoring DR200/HE and DR300 Digital Recorders are 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

± 6kV contact ± 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

Surge IEC 61000-4-5

± 2 kV for power supply lines ± 1 kV for input/ output lines

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

Not applicable. No cables exceed 3 meters

Not applicable. Northeast Monitoring DR200/HE and

Mains power quality should be that of a typical commercial or hospital environment.

N/A

DR300 Digital Recorders are battery powered.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5% U

(>95% dip in UT)

For 0,5 cycle

40% U

(60% dip in UT)

Not applicable. Northeast Monitoring DR200/HE and DR300 Digital Recorders are battery powered.

N/A

For 5 cycles

70% U

(30% dip in UT)

for 25 cycles

< 5% U

(>95% dip in UT)

for 5 s

Power frequency (50/

3 A/m 3 A/m Power frequency magnetic 60 Hz) magnetic field IEC 61000-4-8

NOTE U

is the a.c. mains voltage prior to application of the test level.

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fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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DR200/HE & DR300 Operator’s Manual Appendices: Appendix D: EMC Information

Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test IEC 60601 test

level

Compliance level

Electromagnetic environment – guidance

Portable and mobile communications equipment should be used no closer to any part of the Northeast Monitoring DR200/HE and DR300 Digital Recorder, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2,5 GHz

3 V

3 V/m



d = 1.2

d = 2.3



P 80 MHz to 800 MHz



P 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 metres (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 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.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast 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 frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

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DR200/HE & DR300 Operator’s Manual Appendices: Appendix D: EMC Information

Recommended separation distances between portable and mobile RF communications equipment

and the Northeast Monitoring DR200/HE and DR300 Digital Recorder

The Northeast Monitoring DR200/HE and DR300 Digital Recorders are 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.

Rated maximum output power of transmitter

150 KHz to 80 MHz

Separation distance according to frequency of transmitter

80 MHz to 800 MHz



d = 1.2

d = 1.2 P

800 MHz to 2.5 GHz

d = 2.3 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 metres (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.

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DR200/HE & DR300 Operator’s Manual Appendices: Appendix E: Extraction of ECG data on 3-channel

Appendix E: 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 generate these files, first analyze the data (actually the flash.dat) from the recorder using any compatible version of the LX Analysis program. At 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

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:

unpackc d1 f1 f2 f3 0

• where d1 is the path to the source datacard file,

for example,

d1= c:\nm\pat\xx\datacard.dat

• f1, f2 and f3 are the resultant binary destina-

tion files, for example: f1 = c:\nm\pat\xx\flashc0.dat

f2 = c:\nm\pat\xx\flashc1.dat

f3 = c:\nm\pat\xx\flashc2.dat

Appendix F: Accessories

NEMCA158 - 2-Lead Patient Cable, Adult Small - 24”

NEMCA135 - 2-Lead Patient Cable, Adult Medium - 30”

NEMCA145 - 3-Lead Patient Cable, Adult Small - 24”

NEMCA146 - 3-Lead Patient Cable, Adult Medium - 30”

NEMCA150 - 3-Lead Patient Cable, Adult Large - 38”

NEMCA144 - 5-Lead Patient Cable, Adult Small - 24”

NEMCA134 - 5-Lead Patient Cable, Adult Medium - 30”

NEMCA149 - 5-Lead Patient Cable, Adult Large - 38”

NEMCA133 - 7-Lead Patient Cable, Adult Medium 30”

NEMH112 - Battery Door

NEMH116 - Belt Clip

NEMH187 - Recorder Pouch and Straps

NEMP00387 - Memory - SD Card

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 channel 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.

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DR200/HE & DR300 Operator’s Manual Appendices: Appendix G: Test Issues

Appendix G: Test Issues

Bug

Problem Version

No.

1054 Find Gateway does not work after the

recorder has been left on for a while.

1486 The DR300 MCOT Parameter check value

does not lock when the recorder is locked.

1503 The Holter recorder should only be set to

Hi Resolution On, or 3-channel. For Holter, 1- and 2-channel do not work in this release. This also affects Both mode recording.

1504 DR300 wireless may malfunction when

the battery is low

Impact on device

Found

safety or

effectiveness

4.42 There is no impact on device performance.

4.46 There is no impact on device performance as MCOT is not yet enabled.

4.46 If the recorder is set to record Holter in 1 or 2channel, it will not work.

4.46 The recorder may stop sending wireless transmits for the short term, but a new battery will fix the problem.

Plan to correct, if

applicable

There is no plan to correct.

This will be corrected in the next release with MCOT.

This will be corrected in the next release.

There is no way to fix this, but we will improve the Low Battery message to be more sensitive when Wireless is turned on.

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