Intended use
1.2 Side effects / Residual risks
1
Page 2
Side effects
Temporary cold-related skin damage can occur, especially in sensitive patients.
Intended purpose
Cold air therapy devices are intended to cool the surface of the patient’s skin
locally and contactlessly. The area of application encompasses physical
therapy in pain and inflammatory processes of the musculoskeletal system as
well as aesthetic medicine as a supportive cooling procedure in combination
with cosmetic treatments such as laser therapy or injections for pain reduction.
Target patient group
Age
Age 3 years and over
Sex
No limitations
Potential patient
group
The patients must be able to perceive pain and communicate.
Patients who have at least one of the contraindications listed
may not be treated.
Weight
No limitations
User
Cold air therapy devices are intended exclusively for medical professionals, such
as authorised physicians, therapists, and medical paraprofessionals. Cold air
therapy devices are not intended for use by laypersons or in home care.
State of health:
The user may not have any visual, hearing or colour vision
impairment which interferes with safe device operation and use.
Residual risks:
If the device is used within its intended purpose, no other unacceptable
residual risks are known besides the side effects and the warnings already
mentioned.
Anticipated clinical
efficiency:
Pain reduction through pain-relieving cold air therapy.