Intended Use; Indications; Intended User; Patient Population - EMS DOLORCLAST Instructions For Use Manual

Intended Use

The device has been developed for pain therapy. The
DOLORCLAST Radial Shock Waves is intended for the
®
application fields described below, provided the affected
parts of the body (tendons, muscles, bones, ligaments,
nerves, and skin) can be reached by and safely treated
with the radial extracorporeal shock waves.

Indications

• Tendinopathies (both firstly diagnosed and chronic
ones),
• Adhesive capsulitis (such as shoulder adhesive
capsulitis),
• Trigger points and myofascial pain syndrome,
• Chronic muscle pain and acute muscle aches with
no pathological correlate of injuries such as strains,
bruises, sprains, muscle fiber tears, etc.,
• Chronic lumbar and cervical pain with no patho-
logical correlate of injuries and diseases such
as vertebral fracture, herniated vertebral disk,
spondylodiscitis, spondylolisthesis, ankylosing
spondylitis, primary and secondary bone tumors,
bacterial and/or viral inflammations, etc.,
• Superficial nonunions, stress fractures, and
Osgood-Schlatter disease,
• Painful exostoses such as heel spur, Haglund's
deformity, etc.,
• Knee osteoarthritis,
• Stimulation of acupuncture points in pain
management,
• Proliferative connective tissue disorders such as
plantar fasciopathy, and induratio penis plastica
(Peyronie's disease),
• Spasticity (caused by, e.g., cerebral palsy),
• Skin diseases such as chronic soft tissue wounds,
primary and secondary lymphedema and cellulite
with no pathological correlate of diseases such
as local tumors, local bacterial and/or viral inflam-
mations.
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Intended User

The device must be used by qualified health experts (such
as doctors and physiotherapists) in hospitals, clinics,
medical universities and physical therapists' offices.
They must use this device by fully complying with their
respective country's regulations, accident prevention
measures, and strictly follow these instructions for use.
No specific training other than initial professional training
is required to use this medical device.
The practitioner is responsible for performing the clinical
treatments and for any dangers that may arise due to a
lack of skill and/or training.

Patient population

• Adult population (including breast-feeding women)
who suffer from the diseases outlined in the
"Indications" section and who do not meet contra-
indications.
• Pediatric population who suffer from Osgood-
Schlatter disease and who do not meet contra-
indications

Contraindications

Use of the product is contraindicated in patients with
any of the following conditions:
• Treatment over air-filled tissue (lung, gut),
• Treatment of pre-ruptured tendons,
• Treatment of pregnant women,
• Treatment of patients under the age of 18 (except
for the treatment of Osgood-Schlatter disease),
• Treatment of patients with blood-clotting disorders
(including local thrombosis),
• Treatment of patients treated with oral anticoag-
ulants,
• Treatment of tissue with local tumors or local
bacterial and/or viral infections,
• Treatment of patients treated with cortisone (within
the 6-week period following the last local cortisone
injection).
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