APPENDIX
BEFORE Y
OU BEGIN
THINGS T
O KNO
W
FREQUENTL
Y
A
SKED QUES
TIONS
PAGE 21
Mobile Cardiac Outpatient Telemetry
Addendum to the Patient Education Guide – Model CN1006 (C5)
Indications for Use:
The Ambulatory ECG Monitor with Arrhythmia Detection intended use is for:
1.) Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as
supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including
after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
2.) Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown
etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
3.) Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
4.) Patients who require outpatient Monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) Monitoring of
effect of drugs to control ventricular rate in various atrial arrhythmia (e.g. atrial fibrillation).
5.) Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
6.) Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias.
7.) Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
8.) Patients requiring measurement, analysis, and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter.
9.) Patients who require Monitoring for potential arrhythmias Based on risk ractors (e.g. atrial fibrillation).
10.) Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes.
Contraindications:
1.) Patients with potentially life-threatening arrhythmias who require inpatient Monitoring.
2.) Patients who the attending physician recommends should be hospitalized for ECG Monitoring.
3.) This device should not be used for Monitoring of QT interval during the initiation of antiarrhythmic therapy, where in-hospital Monitoring is required by the labeling of that drug.
4.) The device does not replace the QT interval measurement by a trained observer using diagnostic 12-lead ECG in a clinical environment. This device is not intended to sound any alarms
for QT interval changes.
5.) The device does not annotate QT interval for QRS durations >160 ms or for T wave amplitudes
≤
5% of the peak QRS amplitude.
FOR USE ON ADULT AND PEDIATRIC PATIENTS ONLY The MCOT System is intended for use on adults and children. It is not intended to be used on infants weighing less than 10 kg (22 lbs.).
Precautions
DISPOSE OF BATTERIES PROPERLY
Observe all local laws for the disposal of alkaline batteries.
WHEN NOT IN USE, REMOVE Sensor BATTERY
Do not leave the battery in the Sensor when it is not in use.
AVOID ELECTROMAGNETIC INTERFERENCE
For the best recording results, you should avoid close proximity to heavy equipment or other sources of electromagnetic interference such as electric blankets, heating pads, water beds, etc.
POTENTIAL FOR ELECTROMAGNETIC INTERFERENCE
There is a potential for electromagnetic interference to other devices while using the MCOT System.
USE WITH IMPLANTED PACEMAKERS AND ICDs ( DEFIBRILLATORS)
If you have an implanted pacemaker or defibrillator (ICD), the manufacturer may have recommended you take certain
precautions when using a cellular phone. Since the Monitor contains a cellular phone, you should take the same precautions when carrying and using the Monitor. In general, most manufacturers
recommend the following:
• You should keep a distance of at least six inches (15 cm) between the cellular phone and a pacemaker or defibrillator.
• You should hold the cellular phone on the opposite side of the body from the pacemaker or defibrillator.