6
1.
INTENDED USE
QALM
is a medical
device designed to be
used in the home
healthcare environment for the
treatment and prevention of
frequent episodic and chronic
migraine headaches.
It is suitable for use by all who
can control the device and
understand the instructions.
It may be used by a child from
the age of 8 if supervised by an
adult, but there is currently no
evidence of effectiveness for
users under the age of 18.
Do not use the device for any
purpose other than this intended
use.
2.
CONTRAINDICATIONS,
WARNINGS &
CAUTIONS
CONTRAINDICATIONS:
Do not use if you have
unresolved brain or
facial injuries.
Do not use
QALM
on
any other areas apart
from the forehead. Use on the
chest or neck may affect heart
or implanted devices and may
affect
epileptic
seizure
threshold. May also affect body
worn monitoring devices.
Do NOT use if you have,
in the area being
treated: active or suspected
cancer or undiagnosed pain
with a history of cancer.
Stimulation directly through a
confirmed
or
suspected
malignancy should be avoided
as it may stimulate growth and
promote spread of cancer cells.
WARNINGS:
After a
QALM
session,
wait an hour before
undertaking an activity
that requires concentration.
