Intended use
The BlueTouch Pain Relief Patch is a wearable
medical device intended for use on and by persons
older than 18. It treats muscular back pain by
supplying light and warmth to the body by means
of optical power and thermal conduction. Its special
blue LED light relaxes and helps to heal damaged
muscles through improved blood circulation. The
intended treatment area of the device is the upper
and lower back. You can position the device on the
treatment area with a strap and use it during your
normal daily activities. The power for the device comes
from non-exchangeable rechargeable batteries.
Contra-indications, reactions and side effects
Contra-indications
General health conditions
Do not use the device if any of the following general
health conditions apply to you:
- pregnancy or breastfeeding
- fever
- uncontrolled high blood pressure or a
cardiovascular condition (stroke, myocardial
infarction, angina pectoris, arteriosclerotic vascular
disease (ASVD), peripheral vascular disease, or
(severe) congestive heart failure)
- severe or uncontrolled diabetes or diabetes with
peripheral damage
- presence of an implanted medical device
(screw, etc.) in or near the treatment area
or presence of an active implantable medical
device, such as a cardiac pacemaker, defibrillator,
neurostimulator, cochlear implant, or an active
drug administration device, anywhere in the body
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