NorthEast Monitoring DR200/HE, Operator'S Manual

Page 1: ...Part number NEMM019 Rev O Last updated September 2018 Copyright 2006 2018 All rights reserved DR200 HE and DR300 Digital Holter Event Recorder Operator s Manual ...

Page 2: ...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...

Page 3: ...lter 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 teleme try monitoring for patients...

Page 4: ... 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 Wireless Specifications The DR300 recorder is equipped with wireless Bluetooth transmitter A NorthEast Monitoring DR300 Gateway and Bluetooth USB Dongle is able to re...

Page 5: ... 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 res idential installation This equipment generates uses and can radiate ra...

Page 6: ...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 ordi nances and manufacturer s instructions Storage Capacity The patient s Holter data ...

Page 7: ... Downloads Documents page Wireless Bluetooth DR300 only The DR300 digital recorder is enabled for wireless Bluetooth trans mission In order for wireless trans mission 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 th...

Page 8: ...ing 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 ch...

Page 9: ...red over rib Note The 7 lead hook up shown below consists of independent bipolar leads and corresponds to IEC60601 2 47 requirements Code 2 The 5 electrode hook up does not have independent leads and so does not corre spond to either Code 1 or 2 but is widely used in the United States and Canada 7 LEAD PLACEMENT Channel 1 Red 5th rib left anterior axillary line White right manubrium Channel 2 Brow...

Page 10: ...e 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 dam age 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 ...

Page 11: ...ess 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...

Page 12: ...ng will continue As of firmware version 1 09 restart time is up to 60 minutes but for firmware ver sions 1 08 and earlier it is only up to 10 min utes When the battery is reinserted during the allowed time the LCD returns to the time of day and continues to record the patient s Holter signal When the patient s recording is ana lyzed the signal recorded while the batteries were not in place appears...

Page 13: ...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 Channel 1 Red 5th rib left anterior axillary line White Right manubrium Channel 1 Lead 1 Black Le...

Page 14: ...cording 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 count down Interrupt the countdown with the button sequence ENTER down arrow up arrow and EVENT and the go to the Gen eral Settings menu to change t...

Page 15: ...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 tele phone 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 ...

Page 16: ... 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...

Page 17: ...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 ...

Page 18: ...putting in a fresh battery but if this does not solve the problem call your receiving cen ter 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 your next transmission is successful be sure to replace the battery before you send any transmissions to the receiving...

Page 19: ...ress 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 15 second countdown a...

Page 20: ... 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 pedia...

Page 21: ...ts 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 Fibril...

Page 22: ...s been corrected This error message can be turned off in General Settings 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...

Page 23: ... 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 ...

Page 24: ...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 Chapt...

Page 25: ...ve 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 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 fol lo...

Page 26: ...n 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 thei...

Page 27: ...refrig erators 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 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 bat teries is not recommended Nickel Metal Hydride NiMH This class of batteries is rech...

Page 28: ... 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 prob lems inherent with the analysis of Holter recordings from patients with pacemakers A pacemaker is designed to initiate cardiac conduc tion by stimulating a spot on the myocardium with a pulse of 1 4 volts and a...

Page 29: ...SD 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 ampli tude 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 o...

Page 30: ...gnetic 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 guidance RF emissions CISPR 11 Group 1 Northeast Monitori...

Page 31: ...rst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable No cables exceed 3 meters Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth Not applicable Northeast Monitoring DR200 HE and DR300 Digital Recorders are battery powered N A Voltage dips short interruptions and volta...

Page 32: ...g 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 a should be less than the compliance level in each frequency range b 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 ...

Page 33: ...ng to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 KHz to 80 MHz d 1 2 P 80 MHz to 800 MHz 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 rec...

Page 34: ...y 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...

Page 35: ...no impact on device performance as MCOT is not yet enabled This will be corrected in the next release with MCOT 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 4 46 If the recorder is set to record Holter in 1 or 2 channel it will not work This will be corrected in the next rel...