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Holter Mode: Detection of Arrhythmias, Efficacy of Pharmacological Treatment and Pacemaker Evaluation. Event Recorder: 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). Once data is recorded, the data is transmitted for evaluation.

The DR300 is an ambulatory monitor, sometimes called a Holter, which is a painless method to monitor the heart beat for a period of time (such as 24 hours, 48 hours, or 72 hours). The Holter is a small recording device that records the heart beat while being worn by the patient. The physician or technician places electrodes and wires on the patient. The wires are connected to the Holter or digital recorder. The DR300 Recorder has two modes that allow it to be used either as a standard Holter monitor or a looping Event recorder. The device is designed to facilitate ambulatory cardiac monitoring on the order of a physician, of those patients (including infants weighing less than 10 kg) who may benefit from such monitoring. The data obtained during monitoring is not analyzed at the time of recording. After the recording is complete, the data must later be downloaded to a compatible NorthEast Monitoring Holter or Event analysis system (TelePro Software) to be analyzed. The Holter Analysis Software was cleared by FDA under K930564. The device is not intended to replace real time telemetry monitoring for patient suspected of having life threatening arrhythmias. The DR300 Digital Recorder package includes: - . DR300 Digital Recorder - Operation Manual - SD Card ● - Patient Cable The DR300 digital recorder is powered by one 1.5 volt AA alkaline battery (MN1500 or the equivalent), one AA rechargeable NiMH (nickel metal hydride) battery, or one AA Eveready Lithium L91 battery. Batteries should not be re-used for a second patient. The batteries are not included; users are instructed to purchase 2 AA batteries. The device is compatible with standard silver / silver chloride ECG electrodes. Electrodes are not provided with the subject device. The user is instructed to purchase standard silver / silver chloride ECG electrodes. The DR300 digital recorder uses NorthEast Monitoring NorthEast Monitoring shielded patient cables with either 5 or 7 patient leads for a 3 channel recording or three leads for 2 channel Holter Recording. The DR300 has an LCD that is used to display the time of day (during the recording), prompts and error messages (during the hookup procedure or during recording), or lead quality (during the hookup procedure). The data collected by the DR300 digital recorder is stored on a removable SD Card. The DR300 is packaged in a plastic bag in a cardboard shipping carton. The shipping carton will also include a patient cable and an SD Card. The difference between the DR300 and the DR200/Telaheart is the wireless capability. The DR300 digital recorder is equipped with wireless Bluetooth transmitter. A NorthEast Monitoring Bluetooth Gateway or USB Dongle is able to receive the encrypted Holter and Event data. In order for the wireless transmission to occur, the DR300 will need to come in range of a North East Monitoring transceiver - either a gateway or a PC with a USB Adapter. If there is sufficient data to send, the recorder will attempt to locate a transceiver every 20 minutes. When the transceiver is found the data will be sent. Transmission may be started manually by pressing the enter button.

Intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital, or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is receiled to sinus rhythm in nature.

Holter LX Analysis is a software option to the Holter for Windows software (K930564). The software has been designed to detect sleep disordered breathing due to obstructive apneas or hyponneas. The software uses 2 channel ECG and oximetry data collected via the DR180+ Holter Recorder to calculate the patient's Apnea-Hypopnea Index (AHI). The Holter and Oxymetry ECG data obtained by monitoring is not analyzed at the time of recording is complete, the data must be downloaded to a compatible NorthEast Monitoring Holter LX Analysis with sleep apnea software system to be analyzed by a healthcare professional. The sleep apnea monitoring algorithm used in the subject device is the exact algorithm already cleared by FDA. The Sleep Technician or Physician will utilize standard Holter procedure to hook up the recorder to the patient. The patient will sleep with the recorder for one night in order to collect data. Either the patient or a sleep clinician will note the time that the patient falls asleep and awakens. The sampling rate is 180 samples/second. The Holter LX Analysis software detects each R-wave. The calculations of AHI are performed. The Holter LX Analysis software can only be used in conjunction with North East Monitoring Holter recorders.