Vion 880E Instructions For Use Manual page 4

INDICATION FOR USE
Vion. ECG Pen (Model: 880E/870E) is intended to be used in
measuring heart rate, recording and analyzing ECG signal, then
storing and displaying general information for adult population
who are concerned about their heart conditions during everyday
life. This Vion ECG Pen 880E/870E allows users to record
transient cardiac events up to 9 leads voluntarily anytime or at
the time of symptomatic cardio discomfort
. The recorded ECG signals can be
instructions of a physician)
promptly transferred to personal mobile devices such as
computers(870E not applicable) or cellular phones. At the same
time, these data can be transmitted to physician as reference
immediately, during office visits, or for telemedicine purpose.
This device is capable of measuring and displaying up to 9
(when used under the
INDICATION FOR USE
individual channels of electrocardiogram (ECG) rhythms. Vion
ECG Pen 880E/870E can also detect the presence of atrial
fibrillation, bradycardia, tachycardia, and normal sinus rhythm
(when prescribed or used under the care of a physician). This
device is intended to be used by healthcare professionals,
patients with known or suspected heart conditions, and healthy
individuals.
While Vion ECG Pen 880E/870E is a state of the art home-use
ECG medical device for self-monitoring and record-keeping of
users' cardio conditions, but it is not intended to substitute a
conventional 12 leads ECG diagnostic tool.
Users with implanted pacemakers are not recommended to use
this device.