6.15 Patient population
a) Age: > 18 to geriatric.
b) Weight: Not relevant.
c) Height: Not relevant.
d) Gender: Not relevant.
e) Pregnancy: Not recommended. Avoid treatment of the abdominal region. There is, however, no evidence of any known risks for
either the mother or fetus.
f) Nationality: Not relevant.
g) Skin color: Light or slightly pigmented. Absorption of light in dark/black pigmented skin can result in less effective treatments.
Absorption of light in dark/black pigmented skin, hair and tattoos can cause discomfort by heat absorption.
h) Hair color: High power (> 300 mW) may cause discomfort on dark/black hair. See Note 1.
i) Implants, prosthesis, artificial limbs: Not relevant.
j) Reduced sight or blindness: Not relevant.
k) Reduced hearing or deafness: Not relevant.
l) Reduced mobility or paraplegic: Not relevant.
m) Psychological or intellectual disorders and conditions: Caution should be taken when treating patients potentially unable to respond
to pain. See Note 1.
n) Alcohol or tobacco user: Not relevant.
o) Part of body to be treated: The gut/belly or abdomen area, as well as the back of the neck.
p) Body modifications/changes: Tattoos can absorb light and result in less effective treatments. Dark colors can absorb enough light to
cause discomfort. See Note 1.
q) State of the patient: Awake and conscious. The patient should be able to respond to pain. See Note 1.
r) Medications, drugs, anesthetics: Caution should be taken when treating patients on drugs, medications or anesthetics reducing skin
sensitivity or ability to respond to pain. See Note 1.
s) Cosmetic products: Skin care and cosmetic products, oils, creams and lotions that have been placed on the skin can reduce the
effect of the treatment by the absorption of light, cause damage to electrical components, and render the hygienic handling and
cleaning of the device more difficult. In addition, cosmetic products may also absorb enough light to possibly cause discomfort. See
Note 1.
Note 1) The discomfort a patient may experience is similar to that of a needle prick. Either stop the treatment or constantly move the
device a little between two points. Treatment with the device should always be pain free.
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