20
5. GENERAL SAFETY
Before turning on the device for the first time, read this manual carefully.
The device may only be used under the supervision of the physician prescribing the treatment.
Do not use on bare skin. It is recommended to utilize a protective sheath for treatment
.
All personnel must be properly trained before using the device. This training should include the
servicing technique, maintenance, and verification of proper functioning and safety precautions
associated with using the device.
Shockwave therapy requires bodily contact, therefore do not use it on damaged skin
Do not apply shockwave therapy: To areas of the body with gas-containing organs, close to large
nerve bundles or blood vessels, on the spinal cord, or on the head.
We do not recommend applying shockwave to the body parts under local anesthesia.
The device does not use any drugs, creams, gels, or other substances.
The device is equipped with a protection system that prevents the connection of accessories
other than those supplied by the manufacturer. It will not operate with equipment from other
manufacturers.
Only the power supply adapter approved and supplied by the manufacturer, complying with the
specifications of the machine, may be connected to the device.
The product complies with Class A emissions according to CISPR11, IEC 60601-1-2.
Portable and mobile high-frequency communication devices (such as mobile phones) may affect
the function of the device.
The electrical cables which are to be connected to the device must be installed and tested
according to the existing valid standards (IEC 364). If it is not known whether cables are safe
and/or correct, then they should be checked and/or upgraded by an inspection engineer.
Check whether the parameters of the main power supply correspond to the requirements of the
device according to the machine’s specification.
The device requires the environmental conditions that are stated in the Technical Parameters
section. It must not be used in an environment where there is a danger of explosion or of water
penetrating the device. The device cannot be in connection with flammable anesthetics or
oxidizing gasses (O2, N2O, etc.).
Do not place the device in direct sunlight or near strong electromagnetic fields to prevent
mutual functionality influence. If this happens, move the device further away from the source of
interference or contact an authorized service department of our company.
Inspect the device thoroughly before each use. Look for loose cables, cracked cable insulation,
cracks in the shockwave applicator’s housing and functional behavioral differences in the display
or the operating elements. If any anomalies or inconsistencies are found, stop using the device
and contact an authorized Refine USA service department. If the behavior of the device shows
any divergences from the functionality procedures described in this user’s manual, stop using
the device and contact an authorized member of the service department.
If the device shows any defects or if there are any doubts concerning its correct and safe
functioning, terminate therapy immediately. If the source of the concern can be determine after
a thorough study of the user's manual, then contact an authorized service department
