LifeWatch ECG Mini, User Manual, Page: 8 / 59

Page 8
1 INTRODUCTION
1.1 Intended Use
The ECG Mini System is intended for use by patients who experience
transient symptoms that may suggest cardiac arrhythmia. The
device continuously monitors patient ECG and transmits the
recorded data wirelessly to a monitoring center. The monitoring
center provides the ECG data to the medical practitioner for
evaluation.
The device has not been tested for and it is not intended for pediatric
use.
Contraindications for Use:

The ECG Mini is not to be used in a magnetic resonance
imaging (MRI) environment. The ECG Mini must be removed
from the patient’s skin before he/she undergoes MRI
procedure

The ECG Mini is not to be used with external defibrillator.

The ECG Mini is not a “life-saving” or therapeutic device; the
ECG Mini supplies vital signs data to a doctor or technician
for the purpose of diagnosis by such (or other qualified)
personnel

The ECG Mini is not intended for use on patients with
unhealed surgical incisions/dressings on the thoracic or
abdominal regions

The ECG Mini is not intended for use on patients with skin or
soft tissue damage in the area where the Patch is placed
(such as burns, irritation, infections, wounds, etc.).

The ECG Mini is not intended for use in the diagnosis of
myocardial infarction or for chest pain monitoring.