Side-Effects; Required Qualification; Intended Use - Cheyenne HAWK PEN Operating Instructions Manual

2.5

Side-effects

In a few cases, the tattooing process may
result in minor side effects.
Inform the customer about all risks and
about the side-effects described below.
Frequent:
Pain on the day after tattooing
Inflammation reactions, haematomas,
erythema and oedema in the first three
to five days after tattooing
Skin irritations (e.g. itching or heating),
which normally wear off during the first
12 to 48 hours after tattooing
Rare:
Hyper-pigmentation with body's own
pigments, in particular on dark skin
types, but that disappear completely
a few weeks later
Formation of scabs, small pimples or
skin eruptions if skin is not cleaned
carefully after tattooing
Retinoid reaction (slight irritation up to
peeling of skin)
Possible heating of the tattooed area
when exposed to PET and MRT radiation
Contact allergy to ink pigments or
allergic reactions to other components
of the aseptic ink
23 EN
Furthermore, the following problems
can occur in response to tattooing:
Ink shade differences
Pigment loss
2.6 Required qualification
The HAWK PEN may only be used by
people who have acquired the following
knowledge:
Basic knowledge of the tattooing
process, in particular correct insertion
depth and frequency
Knowledge of the hygiene and safety
regulations (see Page 21)
Knowledge of the impact of tattoo ink
below the skin
Knowledge of the risks and side-effects
(see chapters "Contra-indications"
on page 22 and "Side-effects" on
page 23).
2.7

Intended use

The HAWK PEN is a professional
tattooing machine for the application of
tattoos to the human skin in dry, clean
and smoke-free environments, and under
hygienic conditions. It must be prepared,
used and maintained in the manner
described in these operating instructions.
In particular, the applicable provisions for
workplace layout must be observed, and
all materials used must be sterile.
Intended use also includes thoroughly
reading and understanding these operating
instructions, in particular the chapter "Important
safety notices".
Unintended use is defined as using the
HAWK PEN or its accessories in a way not
described in these operating instructions,
or failing to comply with its operating
conditions. In particular the tattooing of
mucous membranes, or the eyes, and the
tattooing of minors is prohibited.
Cheyenne HAWK PEN