Intended purpose, indications,
contraindications and side effects
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Caution is indicated in the case of persons:
With sensory disturbances
With strong autonomic dysfunction
With osteoporosis
Who are under the influence of drugs and/or alcohol
The device may not be used on injured skin or mucous membranes.
Side effects
Common side effects include:
(Transient) increased pain, radiating pain
Skin irritation, skin reddening, local skin damage such as skin
erythema, petechial skin bleeding, hematoma, local swelling, transient
numbness
Nausea
Headaches/migraines
Nerve irritation, nerve injury
Rare adverse events include:
Bone injury or fracture occurring post-treatment
Tendon rupture occurring post-treatment
Vascular injury
Exacerbation of the condition
Worsening symptoms
Local soft tissue damage.
Absence of bony connection (in the case of stress fractures)
Pseudathrosis
Intended user
enShock is intended for health care professionals, such as physiotherapists,
doctors and medical assistants.
Target patient
population
enShock should not be used on infants and young children.
enShock should not be used on patients who have any of the contraindications
listed.
Patients must be physically and mentally able to consciously perceive and
express the perception of pain stimuli.
Mode of
action/functional
principle
Piezoelectric crystals produce pressure waves when they are electrically
activated. The crystals are mounted in an array, so that the pressure waves
emitted by each crystal meet in a focal point. The penetration depth is
determined by the chosen gel pad spacer.