Contraindications - EMS EMS560 User Manual

Maintenance: For continuous and safe operation, regular maintenance and
inspection by EMS authorized technicians is required. For the maintenance
procedures and schedule, refer to the Maintenance chapter of this manuall.
Coupling media: Water-based ultrasound gel should be used as coupling
media between the primo radial shockwave applicator membrane and
patient skin. If the Primo Radial Shockwave applicator membrane is not
utilised, no coupling media should be applied as it may enter the projectile
chamber and impair performance.
Cleaning: Proper cleaning of the applicator and main unit is required. For
cleaning instructions, refer to the Maintenance chapter of this manual.
Modification of the Primo radial shockwave EMS560 is not permitted and
may result in a hazardous situation.
Contraindications and warnings
Patients in whom pregnancy is confirmed or suspected.
Children under 18 years old.
Contagious skin disease.
Patient with tumor in the area of treatment.
Implanted devices: Do not apply radial waves on any implanted device. To
reduce the incidence of malfunction, a distance of at least 5 cm shall be
kept between the shockwave applicator and the implanted device. For extra
precaution in case of pacemakers or implantable defibrillators, the pulse
generator should be programmed to a single chamber, non-rate responsive
mode (pacemakers) or to inactive mode (implantable defibrillators) prior to
treatment procedure and evaluated for proper function post-treatment.
Applying radial waves in or near an area where a tumour is known to be
present shall be done under the physician discretion.
Do not apply radial waves to areas suffering from superficial vein
thrombosis.
Patients with skin infection in the treatment area should have precautions
taken in order to avoid cross-contamination.
Primo radial shockwave 560 – OM560EN Iss 3
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