Digital Recorder International User Guide - English Version; Indications For Use - NorthEast Monitoring DR181 Mode D'emploi

Digital Recorder International User Guide – English version
Digital Recorder International User Guide – English version
Use this Guide in addition to the Hook-up Guide or Manual provided with your recorder
The NorthEast Monitoring, Inc. digital recorder is not intended to replace real-time telemetry monitoring
Recorder Use
for patients suspected of having life-threatening arrhythmias and is not for In Vitro diagnostic use.
The NorthEast Monitoring, Inc. digital recorder is a Holter and/or Event monitor designed to facilitate the
ambulatory cardiac monitoring, on order of a physician, of those patients (including infants weighing less
than 10 kg.) who my benefit from such monitoring, including but not limited to those with complaints of
palpitations, syncope, chest paints, shortness of breath, or those who need to be monitored to judge their
cardiac functionality, such as patients who have recently received pacemakers.
The data obtained by monitoring are not analyzed at the time of recording. After the recording is complete,
the data must later be copied to HE/LX Analysis and/or compatible Event system to be analyzed.
The NorthEast Monitoring, Inc. digital recorders meet the AAMI EC-11/EC-38 standard for frequency
response, amplitude accuracy and timing accuracy.
The DR181 recorder is intended to be used for long term ECG and oximetry recordings in formats
Intended Use (DR181)
from 3-CH Holter to continuous 12L formats with the option of replacing 1-CH of the 3-CH
recordings with the continuous oximetry recordings.
1. Holter Mode: Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker
Intended Use (DR200/HE and DR300)
Evaluation.
2. 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).
1. Detection of Arrhythmias: The DR181, DR200/HE and DR300 recorders are indicated for use in

Indications for Use

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 DR181, DR200/HE and DR300 recorders are indicated for use to
determine whether current pharmacological treatment(s) of known arrhythmia is effective by
measuring the frequency and duration of the arrhythmia compared to the frequency and duration
prior to treatment.
3. Pacemaker Evaluation: The DR181, DR200/HE and DR300 recorders are indicated for use to
evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within
prescribed limits.
4. Oxygen: The DR181 recorder is indicated for use for trending of Oxygen Saturation (SpO
blood for periods up to 24 hours. If the device is to be used for home monitoring, periods of activity
or excessive movement are to be omitted due to the artifact that would be generated.
5. The DR181, DR200/HE and DR300 recorders are to be used only on the order of a physician.
NorthEast Monitoring, Inc.
For use with DR181, DR200/HE and DR300 Recorders
NEMM041-REV-D
) in the
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