EMS EMS560 User Manual page 8

Treatment of the following patients shall be subjected to the treating
physician's discretion:
Patients having INR > 2.5, prolonged partial thromboplastin time (PTT) or
prolonged bleeding time and platelet count less than 100,000 per microliter.
Patients receiving an anticoagulant or antiaggregant therapy (e.g., aspirin).
Do not apply radial waves to air-filled areas of the body, i.e., intestines or
lungs.
If patient experiences severe pain/discomfort at the application site during
treatment, the intensity level should be decreased to the highest level that
can be tolerated by the patient.
If patient experiences a vaso-vagal reaction during treatment, the patient
should be reclined to a supine position until symptoms disappear.
In case of patient's history of allergic reaction to alcohol we recommend
using non-alcoholic disinfectants.
Please note that during normal treatment, the applicator will become warm
and the applicator tip may reach 46 Deg C.
Non-continuous operation
The applicator is not intended for continuous operation and at maximum
power a duty cycle of a maximum of 2.5 minutes on and 20 minutes off
between treatments to allow the applicator to cool is recommended.
If this advice is disregarded, a thermal cut out will operate and the
applicator will cease to function – forcing the user to wait until it has cooled
sufficiently.
Adverse events
Potential adverse effects that could occur when using the Primo radial
shockwave treatments include:
Pain.
Petechia.
Superficial hematoma.
Neurosensory conditions: Hypesthesia or Paresthesia.
Rare allergic or sensitive conditions.
8 Primo radial shockwave 560 – OM560EN Iss 3