Idiomas disponibles
Idiomas disponibles
Additional Instructions:
•
All areas are treated with the application of the single array, which
delivers Red light initially, followed sequentially by the Infrared
automatically.
•
Following the initial placement as per diagram and initiation of the
treatment protocol, the first placement will end as indicated by 3
consecutive beeps. In order to continue with treatment, now place the
array onto the next corresponding area according to the instructions
(see pages 10-23). Press the Start/Pause button, which will signal
treatment over the next placement. This will initiate treatment of the
next placement. Repeat for each of the placements required in turn.
•
As one becomes more familiar with the utilization of the system,
placements will be largely dictated by the response of the tissues
treated. These are characterized by reduction of pain, swelling,
discoloration and an improving range of motion.
Should you require further guidance, please call a Meditech service at
1-844-770-0177.
Intended Use
The BIOFLEX
Personal System is used by trained health care profesionals
®
as well as general public and is indicated for use to emit energy in the
red and infrared spectrum to provide topical heating for the purpose of
elevating tissue temperature for temporary relief of minor muscle and
joint pain, arthritis, muscle spasm, relieving stifness, prmoting relaxation
of muscle tissue and temporary increase in local blood circulation.
Target Population
Adults (18+)
Essential Performance
According to IEC 60601-1 Ed. 3.1, Essential performance of a clinical
function, other than that related to BASIC SAFETY, where loss or
degradation beyond the limits specified by the MANUFACTURER results
in an unacceptable RISK. The Essential Performance of the BIOFLEX
Personal Therapy System according to IEC 60601-1 Ed. 3.1, is to not
radiate harmful levels of light to shine in the eyes of the patients,
operators or bystanders.
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MN 421.012 Rev 3
Side Effects
The following may be experienced: pain; bruising and swelling; redness
and inflammation; herpes simplex outbreaks and bacterial infections;
temporary skin lightening or darkening; darkening/lightening of tattoos;
freckle loss or lightening of moles; permanent skin pigment changes;
exacerbation of preexisting skin conditions; and hair loss at the treatment
area.
Contraindications
The use of BIOFLEX
systems is contraindicted: for patients with lupus
®
and other diseases which may be stimulated by light, history of keloids,
recent excessive sun exposure and /or artificial tanning at the treatment
area, recent Patients using photosensitive medications or herbs and
patients who are pregnant. For additional advice consult your personal
physician or consultants at Meditech.
Termination of Treatment
Treatments end automatically, unless one presses the Stop button prior to
that event.
The Treatment Array may be cleaned after each treatment using an alcohol
wipe or a soft, damp cloth. A mild disinfectant may also be used. Do not
immerse or rinse the Treatment Array in water.
The straps may be cleaned in a washing machine using the gentle cycle.
Allow straps to air dry post-washing.
Tips Regarding Use
Always be patient with regard to improvement. Sometimes relief may be
dramatic and at other times it may be slow with only gradual reduction
of symptoms after multiple treatments.
If symptoms are acute, rest as much as possible and avoid movements
which may aggravate the symptoms.
At all times remember that patience is a virtue, along with persistence.
Some conditions and patients respond more rapidly than others but with
due care, a positive response is invariably achieved.
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MN 421.012 Rev 3
